MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-15 for 1.25 HEX TL,GEMLOCK RETEN HXGR1.25 manufactured by Zimmer Dental.
[175056920]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[175056921]
It was reported that the driver became stuck to the implant. The implant was removed and the surgical site was closed. No implant was able to be placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002023141-2020-00090 |
| MDR Report Key | 9591428 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-15 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2017-05-02 |
| Date Added to Maude | 2020-01-15 |
| 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 | 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 | 1.25 HEX TL,GEMLOCK RETEN |
| Generic Name | DRIVER |
| Product Code | NDP |
| Date Received | 2020-01-15 |
| Returned To Mfg | 2019-12-20 |
| Catalog Number | HXGR1.25 |
| Lot Number | 63651231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER DENTAL |
| Manufacturer Address | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-15 |