MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-08-08 for TL+ METAL DISTRACTION / COMPRESSION NUT 50-13010 manufactured by Orthofix Srl.
[154531879]
Analysis of historical records- the devices involved in this event have not been returned to orthofix (b)(4) yet. The devices lot number has not been specified yet. Therefore it is not possible to perform the verification of the historical data. Technical evaluation- the devices involved in this event have not been returned to orthofix (b)(4) yet. The technical evaluation will be performed as soon as the devices are received. Medical evaluation- the information available on the case was sent to our medical evaluator. A preliminary medical evaluation was performed and will be finalized once the results of the technical evaluation are available. As soon as the results of the technical investigation become available, orthofix (b)(4) will provide you with a follow up report. Orthofix (b)(4) continues monitoring the devices on the market. Please kindly refer also to mfr report number 9680825-2019-00049 and mfr report number 9680825-2019-00050.
Patient Sequence No: 1, Text Type: N, H10
[154531880]
The information provided by the local distributor indicates: hospital name: (b)(6) hospital. Surgeon name: dr (b)(6). Date of initial surgery: (b)(6) 2019. Body part to which device was applied: tibia. Surgery description: specified in event description. Patient information: (b)(6) year-old, male, weight (b)(6) kg, height 1. 75 meters, previous health condition: tibia bone loss. Problem observed during: clinical use on patient/intraoperative. Type of problem: device functional problem. Event description provided in english: "last monday, (b)(6), at the (b)(6) hospital, a lengthening surgery for the tibia was performed, with dr. (b)(6) and my person as technical support. During the whole procedure we did very well, the assembly and application of the tutor were good. At the moment that the dr wants to distract the osteotomy, turning the lengthening nuts, four of them are fully consolidated to the bars, blocking the whole system. To solve we had to cut the bars and change the whole part of the assembly that was affected; therefore the osteotomy moved. Finally and in summary, we finished the procedure after correcting the whole problem (the translation could not be completely corrected). We are waiting for the review of said patient ((b)(6) 2019) where he will verify the functioning of the tutor and the post-operative lengthening nuts. The complaint report form also indicates: the device failure caused adverse effects on patient (loss of fracture reduction). The initial surgery was not completed with the device. A replacement device was immediately available to complete surgery. The event led to a clinically relevant increase in the duration of the surgical. Procedure: we had to delay the theatre program, i. E. The following surgeries: an additional surgery was not required. A medical intervention (outpatient clinic) was not required. Copies of the operative reports are not available. Copies of the x-ray images are not available. Patient current health condition: the patient has a follow up meeting with the doctor on (b)(6) 2019. The doctor will keep us informed. Manufacturer reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2019-00051 |
| MDR Report Key | 8872868 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-08-08 |
| Date of Report | 2019-10-01 |
| Date of Event | 2019-07-08 |
| Date Mfgr Received | 2019-09-13 |
| Device Manufacturer Date | 2018-11-19 |
| Date Added to Maude | 2019-08-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERTO DONADELLO |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, ITALY 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal | 37012 |
| Manufacturer G1 | ORTHOFIX SRL |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 37012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TL+ METAL DISTRACTION / COMPRESSION NUT |
| Generic Name | TL+ METAL DISTRACTION / COMPRESSION NUT |
| Product Code | LXT |
| Date Received | 2019-08-08 |
| Returned To Mfg | 2019-08-23 |
| Model Number | 50-13010 |
| Catalog Number | 50-13010 |
| Lot Number | 27421814 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | VIA DELLE NAZIONI, 9 BUSSOLENGO, VERONA, 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-08 |