MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-21 for TOMOFIX OSTEOT CHISEL W/15 397.993 manufactured by Oberdorf Synthes Produktions Gmbh.
| Report Number | 8030965-2019-70463 |
| MDR Report Key | 9354313 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-21 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-11-06 |
| Date Mfgr Received | 2019-11-06 |
| Device Manufacturer Date | 2016-09-12 |
| Date Added to Maude | 2019-11-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOMOFIX OSTEOT CHISEL W/15 |
| Generic Name | CHISEL,SURGICAL INSTRUMENT |
| Product Code | FZO |
| Date Received | 2019-11-21 |
| Catalog Number | 397.993 |
| Lot Number | 9962525 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-21 |