MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-02 for BECHTOL * 11-1557 manufactured by Richards.
[16408456]
While inserting the hip prosthesis into pt's right hip, the hip prosthesis inserter broke. The surgeon managed to remove original prosthesis and insert a new one using a different inserter. The pt had no adverse outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 61102 |
| MDR Report Key | 61102 |
| Date Received | 1997-01-02 |
| Date of Report | 1996-12-31 |
| Date of Event | 1996-12-27 |
| Date Facility Aware | 1996-12-27 |
| Report Date | 1996-12-31 |
| Date Added to Maude | 1997-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECHTOL |
| Generic Name | HIP PROSTHESIS INSERTER |
| Product Code | HXO |
| Date Received | 1997-01-02 |
| Model Number | * |
| Catalog Number | 11-1557 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 61477 |
| Manufacturer | RICHARDS |
| Manufacturer Address | 1450 E BROOKS RD MEMPHIS TN 38116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-01-02 |