MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-14 for SWANSON G4260003 manufactured by Wright Medical Technology, Inc..
[166947077]
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[166947078]
Allegedly, the patient underwent a toe surgery in which a flexible toe hinge was implanted. Approximately 3 years post-op it was found that the implant had broken in two places. The patient underwent a revision surgery to remove the implant which was split at the proximal stem and distally.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2019-00192 |
| MDR Report Key | 9323773 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-14 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-10-18 |
| Date Mfgr Received | 2019-10-18 |
| Date Added to Maude | 2019-11-14 |
| 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 MATTHEW PARRISH |
| Manufacturer Street | 1023 CHERRY RD |
| Manufacturer City | MEMPHIS TN 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWANSON |
| Generic Name | PROSTHESIS, TOE, CONSTRAINED, POLYMER |
| Product Code | KWH |
| Date Received | 2019-11-14 |
| Model Number | G4260003 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-14 |