MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-05-27 for OSTEOMED 320-0024 manufactured by Osteomed.
[62720]
The tip broke off in the pt. A magnet was used to retrieve the part.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027754-1997-00025 |
| MDR Report Key | 93293 |
| Report Source | 07 |
| Date Received | 1997-05-27 |
| Date of Report | 1997-05-15 |
| Date Added to Maude | 1997-05-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTEOMED |
| Generic Name | COUNTERSINK |
| Product Code | HWW |
| Date Received | 1997-05-27 |
| Model Number | NA |
| Catalog Number | 320-0024 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 92132 |
| Manufacturer | OSTEOMED |
| Manufacturer Address | 3150 PREMIER DR. IRVING TX 75063 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-05-27 |