MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-29 for ZIMMER MOTOR SYSTEM 115V N/A 00900125 manufactured by Zimmer Dental.
[140364971]
This report is being submitted to report (b)(4). The following information is unknown at the time of this report: device product code unknown. Pma/510k: unknown. Device manufacture date: unknown. The reported device has been received for evaluation. The investigation has not yet begun. A follow up medwatch will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[140364972]
It was reported that error code 99 was received during implant placement. The doctor unplugged the device and it powered up for 10 seconds, then off again. The procedure was not completed. The osteotomy was closed and the patient will have to return for implant placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2019-00246 |
| MDR Report Key | 8466304 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-02-27 |
| Date Added to Maude | 2019-03-29 |
| 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 | 1900 ASTON AVENUE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER MOTOR SYSTEM 115V |
| Generic Name | DRILL UNIT |
| Product Code | DZA |
| Date Received | 2019-03-29 |
| Returned To Mfg | 2019-03-01 |
| Model Number | N/A |
| Catalog Number | 00900125 |
| Lot Number | SN: 03897 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2019-03-29 |