MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-25 for COUNTER SINK GUIDE 320-0024 * manufactured by Osteomed Corp..
[56994]
While using the self-guided counter sink, the dr noticed that the 1/8" long tip had broken off in the pt's foot. After suctioning the area extensively, the piece of metal was retrieved from the suction canister.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011210 |
| MDR Report Key | 86725 |
| Date Received | 1997-04-25 |
| Date of Report | 1997-04-17 |
| Date of Event | 1997-04-11 |
| Date Added to Maude | 1997-04-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUNTER SINK GUIDE |
| Generic Name | COUNTER SINK GUIDE |
| Product Code | HWW |
| Date Received | 1997-04-25 |
| Returned To Mfg | 1997-04-17 |
| Model Number | 320-0024 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 85910 |
| Manufacturer | OSTEOMED CORP. |
| Manufacturer Address | 3150 PREMIER DR. IRVING TX 75063 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-04-25 |