MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-08-07 for 1520 PROXIMAL JIG manufactured by Depuy Ace Medical Co..
[111223]
Broke. Hosp immediately sent for a new part. The surgery was prolonged 1 1/2-2 hrs waiting for the new part.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020311-1998-00012 |
| MDR Report Key | 181536 |
| Report Source | 07 |
| Date Received | 1998-08-07 |
| Date of Report | 1998-06-25 |
| Date of Event | 1998-05-12 |
| Date Facility Aware | 1998-05-12 |
| Report Date | 1998-06-25 |
| Date Mfgr Received | 1998-06-25 |
| Device Manufacturer Date | 1995-02-01 |
| Date Added to Maude | 1998-08-11 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1520 PROXIMAL JIG |
| Generic Name | INSTRUMENTS |
| Product Code | HWD |
| Date Received | 1998-08-07 |
| Model Number | NA |
| Catalog Number | 1520 |
| Lot Number | E2484 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 176522 |
| Manufacturer | DEPUY ACE MEDICAL CO. |
| Manufacturer Address | 2260 EAST EL SEGUNDO BLVD. EL SEGUNDO CA 90245 US |
| Baseline Brand Name | 1520 PROXIMAL JIG |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 1520 |
| Baseline ID | LOT# E2484 |
| Baseline Device Family | INSTRUMENTS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-08-07 |