MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1997-01-22 for SPINAL CURETTE 23-1042 manufactured by .
[7831004]
The unit in question was received by co without the tip. Examination revealed the tip/cup broke off from the neck of the shank. There is a large crack all around the shaft diameter close to the area where it is welded to the handle. The crack was likely caused by dropping the instrument or by laying heavier instruments on top of it during steriliazation. This device was mfr prior to 1979. Failure can be attributed in large part to prolonged use of the device and in part to normal wear and tear accumulated over a long period of time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219655-1997-00013 |
| MDR Report Key | 63720 |
| Report Source | 06,07 |
| Date Received | 1997-01-22 |
| Date of Report | 1997-01-22 |
| Date of Event | 1996-12-23 |
| Date Added to Maude | 1997-01-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINAL CURETTE |
| Generic Name | CURETTE |
| Product Code | HTF |
| Date Received | 1997-01-22 |
| Model Number | NA |
| Catalog Number | 23-1042 |
| Lot Number | UNK |
| ID Number | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 63875 |
| Baseline Brand Name | SPINAL CURETTE |
| Baseline Generic Name | CURETTE |
| Baseline Model No | NA |
| Baseline Catalog No | 23-1042 |
| Baseline ID | * |
| Baseline Device Family | CURETTES |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-01-22 |