MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for DO NOT USE - OSSEOCISION TM 20:1 HANDPIECE SGM-E20RI manufactured by Biomet 3i.
[178583381]
It was reported that the piece at the top of the handpiece did not allow drills to engage and the handpiece would not spin. The patient was under anesthesia and the dentist was unable to complete the procedure. The patient was sent home and will return at a later date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2020-00311 |
| MDR Report Key | 9693527 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-15 |
| Date Facility Aware | 2020-01-15 |
| Report Date | 2020-02-11 |
| Date Reported to FDA | 2020-02-11 |
| Date Reported to Mfgr | 2020-02-11 |
| Date Added to Maude | 2020-02-11 |
| 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 | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DO NOT USE - OSSEOCISION TM 20:1 HANDPIECE |
| Generic Name | HANDPIECE |
| Product Code | EBW |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2020-01-22 |
| Catalog Number | SGM-E20RI |
| Lot Number | A7300100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET 3I |
| Manufacturer Address | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-11 |