MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-08-12 for IMPLANT, METATARSAL, SIZE 1, R 012002 manufactured by Integra Lifesciences Corporation Oh/usa.
[4897547]
It was reported a kgti great toe metatarsal implant was implanted in 2008. In 2014 "serious instability and bone erosion was noted. On (b)(6) 2014, the implant was removed". Numerous request for additional clinical information were sent to the surgeon.
Patient Sequence No: 1, Text Type: D, B5
[12434932]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2014-00133 |
| MDR Report Key | 4067996 |
| Report Source | 05,07 |
| Date Received | 2014-08-12 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-07-17 |
| Date Mfgr Received | 2014-07-17 |
| Date Added to Maude | 2014-09-09 |
| 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 | CARMEN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANT, METATARSAL, SIZE 1, R |
| Generic Name | NONE |
| Product Code | LZJ |
| Date Received | 2014-08-12 |
| Catalog Number | 012002 |
| Lot Number | 16241-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-12 |