MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-29 for PTS MICRO OSCILLATING SAW 5100-031-000 NA manufactured by Stryker Instruments.
[153429]
Stryker saw was used on operation in the mouth. After operation, when saw was removed, 3-4 cuts were noted at the right commissure of the mouth. They were 5-6 mm in length. The lacerations required suturing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 204435 |
| MDR Report Key | 204435 |
| Date Received | 1998-12-29 |
| Date of Report | 1998-11-16 |
| Date of Event | 1998-11-11 |
| Date Facility Aware | 1998-11-11 |
| Report Date | 1998-11-16 |
| Date Reported to Mfgr | 1998-12-03 |
| Date Added to Maude | 1999-01-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PTS MICRO OSCILLATING SAW |
| Generic Name | SAW, AC, POWERED |
| Product Code | DZH |
| Date Received | 1998-12-29 |
| Model Number | 5100-031-000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 198558 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US |
| Baseline Brand Name | MICRO OSCILLATING SAW |
| Baseline Generic Name | SAW, BONE, AC POWERED |
| Baseline Model No | 5100-031-000 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Baseline Device Family | OSCILLATING SAWS |
| 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 | 1. Required No Informationntervention | 1998-12-29 |