MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-07-05 for FIXTURE REMOVER SCREW M2.0 FRS20 manufactured by Biomet 3i.
[48744385]
The dentist reported that two (2) unknown implants were removed due to the positioning of the implants. While removing the implants the frs20 fixture remover screws fractured inside the implants and the fixture removers. The dentist was unable to disengage the screws from the fixture removers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2016-00149 |
| MDR Report Key | 5768985 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-07-05 |
| Date of Report | 2016-06-06 |
| Date of Event | 2016-06-01 |
| Date Facility Aware | 2016-06-01 |
| Report Date | 2016-06-06 |
| Date Reported to Mfgr | 2016-06-06 |
| Date Mfgr Received | 2016-06-06 |
| Date Added to Maude | 2016-07-05 |
| 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 Contact | MS. DANIA PEREZ |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5617766700 |
| Manufacturer G1 | BIOMET 3I |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXTURE REMOVER SCREW M2.0 |
| Generic Name | REMOVER SCREW |
| Product Code | DZA |
| Date Received | 2016-07-05 |
| Returned To Mfg | 2016-06-06 |
| Catalog Number | FRS20 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-07-05 |