MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-05-01 for MGT MOVEMENT PROX. PHAL. TOTAL SZ 20 manufactured by Ascension Orthopedics.
[4523722]
This is the second report of two reports concerning the same patient. (see mfg report number 1651501-2014-00021). This report concerns the movement great toes system (mgt) movement proximal phalanx. Total size 20 (product id mgt-890-20ppt). It was reported: 'surgery was an mgt total toe. Surgery went fine but the patient soon began to have pain. The surgeon went back in to replace the implant and found that the cobalt chrome had peeled off the head of the implant. ' additional information was received from the distributor on (b)(6)-2014. The date of the initial implant surgery was (b)(6)-2013. The implant was implanted in the left foot of the patient. The patient had discomfort soon after the surgery which progressed until the implant was removed (and toe was later fused) on (b)(6)-2014. The patient condition to date was reported as 'improved'. The implant was reported given to the patient and is not available for evaluation. Additional information was requested by integra.
Patient Sequence No: 1, Text Type: D, B5
[11785675]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2014-00022 |
| MDR Report Key | 3810009 |
| Report Source | 05,08 |
| Date Received | 2014-05-01 |
| Date of Report | 2014-04-07 |
| Date Mfgr Received | 2014-04-07 |
| Date Added to Maude | 2014-05-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 085363832 |
| Manufacturer Country | US |
| Manufacturer Postal | 085363832 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MGT MOVEMENT PROX. PHAL. TOTAL SZ 20 |
| Generic Name | MOVEMENT GREAT TOE |
| Product Code | LZJ |
| Date Received | 2014-05-01 |
| Lot Number | 10-1204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | AUSTIN TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-01 |