MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-05-29 for MINI-OSTEOTOME, STRAIGHT, 2MM 55-0621 manufactured by Smith & Nephew, Inc. Ent Div..
[17170841]
After tapping on the osteotome, the physician thought that the instrument looked shorter than before use. He thought that it would be better to leave the piece in the bone rather than remove it. Fluoroscopy indicated that a piece of the instrument less than 2 mm was left lodged in the bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037007-1998-00001 |
| MDR Report Key | 170835 |
| Report Source | 05 |
| Date Received | 1998-05-29 |
| Date of Report | 1998-05-28 |
| Date of Event | 1998-04-28 |
| Date Added to Maude | 1998-06-04 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINI-OSTEOTOME, STRAIGHT, 2MM |
| Generic Name | INSTRUMENT |
| Product Code | JYE |
| Date Received | 1998-05-29 |
| Model Number | NA |
| Catalog Number | 55-0621 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 166164 |
| Manufacturer | SMITH & NEPHEW, INC. ENT DIV. |
| Manufacturer Address | 2925 APPLING RD. BARTLETT TN 38133 US |
| Baseline Brand Name | MINI-OSTEOTOME |
| Baseline Generic Name | OSTEOTOME |
| Baseline Model No | NA |
| Baseline Catalog No | 55-0621 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| 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 | 1. Other | 1998-05-29 |