MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-02 for * 423868 manufactured by Biomet, Inc..
[21690233]
During surgical procedure, left total hip revision, tip of ultrasonic device broke, while removing cement. Tip of device left in left femoral canal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 96028 |
| MDR Report Key | 96028 |
| Date Received | 1997-06-02 |
| Date of Report | 1997-05-12 |
| Date of Event | 1997-05-05 |
| Date Facility Aware | 1997-05-05 |
| Report Date | 1997-05-13 |
| Date Reported to Mfgr | 1997-05-13 |
| Date Added to Maude | 1997-06-06 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | * |
| Generic Name | ULTRA DEVICE TOOL 6MM PLUG PULLER |
| Product Code | LZV |
| Date Received | 1997-06-02 |
| Model Number | * |
| Catalog Number | 423868 |
| Lot Number | 1625809704 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 94818 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | P.O. BOX 587 WARSAW IN 46580 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-06-02 |