MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-04-07 for LAMBOTTE OSTEOTOME, CURVED OS1061-006 manufactured by August Reuchlen-instrumente.
[19897027]
Osteotome broke off in pt's bone. The dr was able to retreive it with a plier. No additional treatment required. Dr was performing a knee anterior cruciate ligament graft and arthroscopy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000008-2000-00002 |
| MDR Report Key | 272600 |
| Report Source | 05,06 |
| Date Received | 2000-04-07 |
| Date of Report | 2000-04-07 |
| Date of Event | 2000-03-22 |
| Date Facility Aware | 2000-03-28 |
| Report Date | 2000-04-07 |
| Date Reported to FDA | 2000-04-07 |
| Date Reported to Mfgr | 2000-04-07 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2000-04-10 |
| 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 |
| Manufacturer Street | JUNKERSTRASSE 8 |
| Manufacturer City | TUTTLINGEN D-78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-78532 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAMBOTTE OSTEOTOME, CURVED |
| Generic Name | INSTRUMENT |
| Product Code | GFI |
| Date Received | 2000-04-07 |
| Returned To Mfg | 2000-04-06 |
| Model Number | OS1061-006 |
| Catalog Number | OS1061-006 |
| Lot Number | T |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 263904 |
| Manufacturer | AUGUST REUCHLEN-INSTRUMENTE |
| Manufacturer Address | JUNKERSTRASSE 8 TUTTLINGEN GM D-78532 |
| Baseline Brand Name | LAMBOTTE OSTEOTOME, SURVED |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | OS1061-006 |
| Baseline Catalog No | OS1061-006 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-04-07 |