MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-04-30 for OSTEOMED 320-0024 manufactured by Osteomed Corp..
[58499]
The tip of the co self-guided manual counter-sink broke off during surgery. The surgeon suctioned the area extensively and the piece of the counter sink was retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027754-1997-00023 |
| MDR Report Key | 88088 |
| Report Source | 06 |
| Date Received | 1997-04-30 |
| Date of Report | 1997-04-25 |
| Date of Event | 1997-04-11 |
| Date Mfgr Received | 1997-04-17 |
| Date Added to Maude | 1997-05-05 |
| 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 | MANUAL COUNTER SINK |
| Product Code | HWW |
| Date Received | 1997-04-30 |
| Model Number | NA |
| Catalog Number | 320-0024 |
| Lot Number | NI |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 85910 |
| Manufacturer | OSTEOMED CORP. |
| Manufacturer Address | 3150 PREMIER DR., #110 IRVING TX 75063 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-04-30 |