MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2010-05-27 for PLATE, CARPAL SMALL 261201 manufactured by Integra Lifesciences Corporation (integra-ohio).
[16372736]
The reporter stated that the patient reported pain at the site of the implant. X-rays were taken and it was noticed that the implant was broken. The patient had a surgical procedure to remove the implanted device. Integra has requested additional clinical information.
Patient Sequence No: 1, Text Type: D, B5
[16567083]
The evaluation of the complaint sample has not been completed. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2010-00042 |
| MDR Report Key | 1702150 |
| Report Source | 01,06 |
| Date Received | 2010-05-27 |
| Date of Report | 2010-05-27 |
| Date of Event | 2010-04-14 |
| Date Mfgr Received | 2010-04-14 |
| Date Added to Maude | 2011-04-27 |
| 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 | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLATE, CARPAL SMALL |
| Generic Name | UNI2 TOTAL WRIST IMPLANT SYSTEM |
| Product Code | KWN |
| Date Received | 2010-05-27 |
| Catalog Number | 261201 |
| Lot Number | 107035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION (INTEGRA-OHIO) |
| Manufacturer Address | PLAYA DEL REY CA 90293 US 90293 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-05-27 |