MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-08-09 for ULTRA-DRIVE DISK DRILL 423871 manufactured by Biomet, Inc..
[22183527]
During utilization of ultra drive cement removal system on 6/28/99, disk portion of tool fractured within the femoral canal. Surgeon elected to window femur to extract tool tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825034-1999-00076 |
| MDR Report Key | 235153 |
| Report Source | 07 |
| Date Received | 1999-08-09 |
| Date of Report | 1999-08-05 |
| Date of Event | 1999-06-28 |
| Date Facility Aware | 1999-06-28 |
| Report Date | 1999-08-05 |
| Date Mfgr Received | 1999-07-06 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 1999-08-16 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA-DRIVE DISK DRILL |
| Generic Name | CEMENT REMOVAL SYSTEM |
| Product Code | LZV |
| Date Received | 1999-08-09 |
| Model Number | NA |
| Catalog Number | 423871 |
| Lot Number | 307770 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 227894 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | PO BOX 587 WARSAW IN 465810587 US |
| Baseline Brand Name | ULTRA-DRIVE DISK DRILL |
| Baseline Generic Name | CEMENT REMOVAL SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 423871 |
| Baseline ID | NA |
| Baseline Device Family | ULTRA-DRIVE DISK DRILL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K900003 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-08-09 |