MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-23 for DRIVER TIP manufactured by Zimmer Dental.
[146630197]
Zimmer biomet complaint (b)(4). Patient information not provided/unknown. Event date not provided/unknown. Device brand name unknown. Device product code unknown. Device catalog and lot number not provided/unknown.
Patient Sequence No: 1, Text Type: N, H10
[146630198]
It was reported that an unknown zimmer driver tip fractured off in the abutment screw (mhlas). The doctor was able to remove the fractured piece from the screw. No impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002023141-2019-00225 |
| MDR Report Key | 8636245 |
| Date Received | 2019-05-23 |
| Date of Report | 2019-08-26 |
| Date Mfgr Received | 2019-08-15 |
| Date Added to Maude | 2019-05-23 |
| 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 SUSANNE TAYLOR |
| Manufacturer Street | 4555 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5617766700 |
| Manufacturer G1 | ZIMMER DENTAL |
| Manufacturer Street | 1900 ASTON AVENUE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | DRIVER TIP |
| Product Code | DZA |
| Date Received | 2019-05-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER DENTAL |
| Manufacturer Address | 1900 ASTON AVENUE CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-23 |