MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-04-21 for PALMAR RADIUS FRACTURE PLATE, SMALL, LONG 54-25289 manufactured by Stryker Leibinger Freiburg.
[73394795]
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device disposition is unknown.
Patient Sequence No: 1, Text Type: N, H10
[73394796]
The patient was operated for fixation of bilateral distal radius fracture with matrix plates on (b)(6) 2016. On (b)(6) 2017, the patient returned to the emergency room with pain. X-ray examinations were performed and it was noticed that plates were broken. It's unknown if a new operation was performed in order to substitute the broken plates. The distributor is trying to contact doctors and/or patient in order to get more information.
Patient Sequence No: 1, Text Type: D, B5
[109941351]
The reported event that a? Palmar radius fracture plate, small, long? Broke after the initial surgery, could be confirmed, based on the provided x-rays. Since the actual? Palmar radius fracture plate, small, long? Was not returned, an inspection could not be performed. It was reported that the plate was implanted in (b)(6) 2016 and the breakage occurred in (b)(6) 2017. The amount of time passed indicates a nonunion. No initial x-ray, showing the fracture prior to orif, or any other further information regarding the patient and his immobilization were communicated. Though, from the provided post-operative x-rays, a clinical expert evaluation revealed that,? Fragment reduction and plate positioning were done correctly. However, the plate has been inserted in (b)(6) child, whereby the plate has been inserted proximal to the distal growth plate of the radius. [?. ] but, there is a distal diametaphyseal forearm fracture (= fracture of the distal radius and the distal ulna proximal to the growth plate) which is a very typical fracture in this age. Usually, such a fracture is reduced and treated with a plaster cast for six weeks. In highly unstable situations additionally one or two k-wires may be inserted, which are removed after 4? 6 weeks. [?. ] in the given case, the surgeon performed orif with a volar matrix plate. The matrix plate is an anatomically pre-shaped plate, which is only intended for orif of adult distal radius fractures, whereby the distal portion of the plate has to be positioned near to the watershed line of the distal radius. This plate features a bending of approx. 25? Which broadly matches with the contour of the bone surface in the area of the volar distal radius epiphysis. But, the volar matrix plate is not intended for positioning of the distal plate portion at the diametaphyseal area proximal to the growth plate (clinical misuse). In this area the plate bending would have to be decreased from 25? To approx. 5? To 10?. This was not done resulting in a significant gap between distal portion of the plate and the bone surface. [?. ] the x-rays after approx. 5 months show breakage of the plate and a manifest non-union of the radius fracture, which is a rarity in this age. The ulna fracture is uneventfully consolidated with slight callus formation (as usual in this age).? As per ifu (90-03200):? The user must be familiar with the state of the art and the instrument and implant function prior to clinical application. [? ] responsibility for proper selection of patients, adequate training, experience in the choice and placement of implants and the decision to leave or remove implants postoperatively, rests with the surgeon. [? ] the correct selection of the product is extremely important. The product should be used in the correct anatomic location, consistent with accepted standards for internal fixation. Failure to use the appropriate product for the application may result in a premature clinical failure. Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, or fracturing of the product and/or bone. [? ] the patient should be advised to report any unusual changes of the operated site to their surgeon. The patient should be closely monitored if a change at the fixation site has been detected. [? ] screw and plate implants are designed to function only until bony healing (usually 6-12 weeks). Delayed healing, non-union or subsequent bone resorption or trauma may lead to excessive stress on the implant(s) and result in loosening, bending, cracking or fracturing. [? ] contouring or bending of an implant should be avoided where possible, because it may reduce the strength and can cause failure under load. If contouring is necessary for anatomical reasons, sharp bends, reverse bends, or bending the device over a screw hole (including elongated screw holes) must be avoided or the implant must be discarded. It is essential to ensure that the desired shape is reached in as few bends as possible. [? ] fracture system implants are not designed to bridge bony gaps. Application of such may lead to premature implant failure.? Therefore, the user should be well educated on the usage of the system and the patient well informed that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future. Based on investigation, the root cause would be attributed to a user related issue, due to a misuse. However, please bear in mind that more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event. A review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. No indications of material, manufacturing or design related problems were found during the investigation. If any further information is provided, the investigation report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[109941352]
The patient was operated for fixation of bilateral distal radius fracture with matrix plates on (b)(6) 2016. On (b)(6) 2017, the patient returned to the emergency room with pain. X-ray examinations were performed and it was noticed that plates were broken. It's unknown if a new operation was performed in order to substitute the broken plates. The distributor is trying to contact doctors and/or patient in order to get more information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2017-00086 |
| MDR Report Key | 6512191 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-04-21 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-03-04 |
| Date Mfgr Received | 2017-06-01 |
| Device Manufacturer Date | 2016-02-24 |
| Date Added to Maude | 2017-04-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER LEIBINGER FREIBURG |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALMAR RADIUS FRACTURE PLATE, SMALL, LONG |
| Generic Name | IMPLANT |
| Product Code | ILH |
| Date Received | 2017-04-21 |
| Catalog Number | 54-25289 |
| Lot Number | 1000203667 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER LEIBINGER FREIBURG |
| Manufacturer Address | BOETZINGERSTR. 41 FREIBURG D-79111 D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-21 |