MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-07-30 for TEBBETTS INTRANASAL OSTEOTOME, 4MM * 88-4050 manufactured by Genzyme Surgical Products.
[108986]
Compainant alleges that a 3mm x 1mm piece of an osteotome broke off during a rhinoplasty procedure. The surgical team was unsuccessful in retrieving the piece from the operative site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038548-1998-00042 |
| MDR Report Key | 179607 |
| Report Source | 05 |
| Date Received | 1998-07-30 |
| Date of Report | 1998-07-30 |
| Date of Event | 1998-07-07 |
| Date Mfgr Received | 1998-07-08 |
| Device Manufacturer Date | 1998-01-01 |
| Date Added to Maude | 1998-07-31 |
| 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 | TEBBETTS INTRANASAL OSTEOTOME, 4MM |
| Generic Name | OSTEOTOME MANUAL |
| Product Code | GFI |
| Date Received | 1998-07-30 |
| Model Number | * |
| Catalog Number | 88-4050 |
| Lot Number | L986929 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 174644 |
| Manufacturer | GENZYME SURGICAL PRODUCTS |
| Manufacturer Address | 5175 S. ROYAL ATLANTA DR TUCKER GA 300843053 US |
| Baseline Brand Name | TEBBETTS INTRANASAL OSTEOTOME, 4MM |
| Baseline Generic Name | OSTEOTOME MANUAL |
| Baseline Model No | * |
| Baseline Catalog No | 88-4050 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-07-30 |