MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-10-01 for COMMAND RECIP SAW 0296-037-999 NA manufactured by Stryker Instruments.
[103224]
Oil is leaking from tip of drill.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1811755-1997-00077 |
| MDR Report Key | 124988 |
| Report Source | 06 |
| Date Received | 1997-10-01 |
| Date of Report | 1997-09-04 |
| Date Facility Aware | 1997-09-04 |
| Report Date | 1997-09-04 |
| Date Mfgr Received | 1997-09-04 |
| Device Manufacturer Date | 1992-02-01 |
| Date Added to Maude | 1997-10-09 |
| 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 | COMMAND RECIP SAW |
| Generic Name | SAW |
| Product Code | DZH |
| Date Received | 1997-10-01 |
| Returned To Mfg | 1997-09-04 |
| Model Number | 0296-037-999 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 122365 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US |
| Baseline Brand Name | COMMAND RECIP SAW |
| Baseline Generic Name | SAW |
| Baseline Model No | 0296-037-999 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-10-01 |