MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-03 for RHOTON-TYPE HOOKS,7 1/2", 90 DEGREE ANGLE, SEMI-S * 227-268 manufactured by Josef Heiss Gmbh.
[329455]
The user facility reported to the distributor in july 2004, the tip of the rhoton hook (90 degree hook) broke off in a pt's neck during anterior cervical procedure. The tip was recovered and there was no effect to the pt. The breakage did not compromise the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2004-00024 |
| MDR Report Key | 542046 |
| Date Received | 2004-09-03 |
| Date of Report | 2004-09-02 |
| Date Facility Aware | 2004-07-26 |
| Report Date | 2004-09-03 |
| Date Reported to FDA | 2004-09-03 |
| Date Reported to Mfgr | 2004-09-03 |
| Date Added to Maude | 2004-09-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHOTON-TYPE HOOKS,7 1/2", 90 DEGREE ANGLE, SEMI-S |
| Generic Name | MICROSURGICAL INSTRUMENT |
| Product Code | GZX |
| Date Received | 2004-09-03 |
| Model Number | * |
| Catalog Number | 227-268 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 531395 |
| Manufacturer | JOSEF HEISS GMBH |
| Manufacturer Address | * TITTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-03 |