MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1997-05-27 for OSTEOMED 450-0240 manufactured by Osteomed Corp..
[61616]
Recip. Saw bent during surgery. Then bork off after cool down.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027754-1997-00027 |
| MDR Report Key | 93756 |
| Report Source | 05,07 |
| Date Received | 1997-05-27 |
| Date of Report | 1997-05-23 |
| Date of Event | 1997-04-19 |
| Date Mfgr Received | 1997-05-07 |
| Date Added to Maude | 1997-06-02 |
| 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 | RECIP SAW |
| Product Code | DZH |
| Date Received | 1997-05-27 |
| Model Number | NA |
| Catalog Number | 450-0240 |
| Lot Number | 9650007 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 92561 |
| Manufacturer | OSTEOMED CORP. |
| Manufacturer Address | 3150 PREMIER DR., #110 IRVING TX 75063 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-27 |