MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2004-06-22 for ARCS ANCHORS * UNK BONE A manufactured by Depuy Mitek.
[336897]
A statement was made to a depuy mitek employee that there was a pt infection involving a depuy mitek product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2004-00083 |
| MDR Report Key | 530791 |
| Report Source | 00,07 |
| Date Received | 2004-06-22 |
| Date of Report | 2004-06-17 |
| Report Date | 2004-06-17 |
| Date Mfgr Received | 2004-06-17 |
| Date Added to Maude | 2004-06-23 |
| 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 | 3 |
| Manufacturer Contact | MR. RONALD GIANNANGELO |
| Manufacturer Street | 60 GLACIER DRIVE |
| Manufacturer City | WESTWOOD MA 02090 |
| Manufacturer Country | US |
| Manufacturer Postal | 02090 |
| Manufacturer Phone | 7812513195 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCS ANCHORS |
| Generic Name | BONE ANCHOR |
| Product Code | NOV |
| Date Received | 2004-06-22 |
| Model Number | * |
| Catalog Number | UNK BONE A |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 520029 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 60 GLACIER DRIVE WESTWOOD MA 02090 US |
| Baseline Brand Name | ARCS ANCHORS |
| Baseline Generic Name | BONE ANCHOR |
| Baseline Model No | UNK |
| Baseline Catalog No | UNK BONE A |
| Baseline ID | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-06-22 |