MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-30 for DRIVER manufactured by Zimmer Dental.
[119335002]
(b)(4). Product not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[119335003]
It was also reported that the driver (unk driver) may be malfunction, it did not hold the implant. It was also reported that the implant (cm3110) fell down on the floor during the procedure. There is no reported impact or harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002023141-2018-00779 |
| MDR Report Key | 7835258 |
| Date Received | 2018-08-30 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-07-06 |
| Date Mfgr Received | 2018-11-21 |
| Date Added to Maude | 2018-08-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 6221 EL CAMINO REAL |
| Manufacturer City | CARLSBAD CA 92009 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | DRIVER |
| Product Code | DZA |
| Date Received | 2018-08-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER DENTAL |
| Manufacturer Address | 6221 EL CAMINO REAL CARLSBAD CA 92009 US 92009 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-30 |