MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-28 for MINI QUICKANCHOR PLUS 212033 * manufactured by Depuy Mitek.
[22099025]
Post-operative x-ray showed a piece of metal retained in patient's foot lying near the bone believed to be fragment of the mitek anchor mechanism that either broke off or detached during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1781449 |
| MDR Report Key | 1781449 |
| Date Received | 2010-07-28 |
| Date of Report | 2010-07-28 |
| Date of Event | 2010-07-10 |
| Report Date | 2010-07-28 |
| Date Reported to FDA | 2010-07-28 |
| Date Added to Maude | 2010-08-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | MINI QUICKANCHOR PLUS |
| Generic Name | SOFT TISSUE FIXATION |
| Product Code | NOV |
| Date Received | 2010-07-28 |
| Model Number | 212033 |
| Catalog Number | * |
| Lot Number | 3395734 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-28 |