MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-06 for ORTHO - LOCK 3X110CM * manufactured by Stryker.
[581577]
While working on pt's right knee, during bilateral total knee replacements, the ortho lock extraction pin broke off leaving approx 2cm of the pin in the pt's right tibia. The physician was unable to retrieve the broken portion and he notified the pt of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041882 |
| MDR Report Key | 812972 |
| Date Received | 2007-02-06 |
| Date of Report | 2007-01-29 |
| Date of Event | 2006-11-02 |
| Date Added to Maude | 2007-02-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO - LOCK |
| Generic Name | EXTRACTION PIN |
| Product Code | HXY |
| Date Received | 2007-02-06 |
| Model Number | 3X110CM |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 800456 |
| Manufacturer | STRYKER |
| Manufacturer Address | 2825 AIRVIEW BLVD KALAMAZOO MI 49002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-06 |