MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-21 for KIRK MALLET 7-1/2 W/1-1/2 HEAD 250400 manufactured by Integra York, Pa.
[2428046]
On (b)(6) 2011, per the surgical director, "the doctor was back slapping an insertion device during a hip replacement procedure and metal chipped off the edge. They believed they got all the chips. No injury reported at this time. " on (b)(6) 2011 the radiologist indicated that a spot on the x-ray may be a metal flake from the instrument. He did not recommend attempting to retrieve the possible flake.
Patient Sequence No: 1, Text Type: D, B5
[9533837]
To date the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2011-00092 |
| MDR Report Key | 2419021 |
| Report Source | 05,06 |
| Date Received | 2011-12-21 |
| Date of Report | 2011-12-21 |
| Date Mfgr Received | 2011-12-09 |
| Date Added to Maude | 2012-04-18 |
| 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 FERNANDEZ |
| 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 | KIRK MALLET 7-1/2 W/1-1/2 HEAD |
| Generic Name | NA |
| Product Code | HXL |
| Date Received | 2011-12-21 |
| Catalog Number | 250400 |
| 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 YORK, PA |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-21 |