MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-19 for ANCHOR 72201542 * manufactured by Smith & Nephew.
[2750979]
Three out of five anchors fell out of the bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2553018 |
| MDR Report Key | 2553018 |
| Date Received | 2012-04-19 |
| Date of Report | 2012-04-18 |
| Date of Event | 2012-03-21 |
| Report Date | 2012-04-18 |
| Date Reported to FDA | 2012-04-19 |
| Date Added to Maude | 2012-04-30 |
| 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 | 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 | ANCHOR |
| Generic Name | IMPLANT - HARDWARE |
| Product Code | NOV |
| Date Received | 2012-04-19 |
| Returned To Mfg | 2012-03-28 |
| Model Number | 72201542 |
| Catalog Number | * |
| Lot Number | 50405219 |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW |
| Manufacturer Address | 3303 E HOLMES RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-19 |