MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2005-05-27 for INTERNAL SCREWDRIVER * 119840 manufactured by Newdeal S.a..
[382227]
Integra representative reported for the user facility that the internal kalix driver used for final placement of the kalix implant snapped at the tip of the instrument. The surgeon was able to retrieve the broken tip and the implant remained in the pt due to successful insertion. However, it was reported that the implanted kalix implant backed out of the foot, requiring a new device to be placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615741-2005-00019 |
| MDR Report Key | 612300 |
| Report Source | 06,07 |
| Date Received | 2005-05-27 |
| Date of Report | 2005-05-27 |
| Date Mfgr Received | 2005-04-22 |
| Date Added to Maude | 2005-06-13 |
| 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 | 0 |
| Manufacturer Contact | YANPING WANG |
| Manufacturer Street | 311C ENTERPRICE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362322 |
| Manufacturer G1 | NEWDEAL S.A. |
| Manufacturer Street | 10, PLACE D'HELVETIE |
| Manufacturer City | LYON 69006 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERNAL SCREWDRIVER |
| Generic Name | KALIX ASSOCIATED IMPLANT INSTRUMENTS |
| Product Code | KXX |
| Date Received | 2005-05-27 |
| Model Number | * |
| Catalog Number | 119840 |
| Lot Number | DIT9 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 602128 |
| Manufacturer | NEWDEAL S.A. |
| Manufacturer Address | * LYON FR |
| Baseline Brand Name | INTERNAL SCREWDRIVER |
| Baseline Generic Name | KALIX IMPLANT ASSOCIATED INSTRUMENTS |
| Baseline Model No | * |
| Baseline Catalog No | 119840 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-27 |