MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-16 for RETAINING 2.5MM HEX DRIVE R LONG RHL2.5 manufactured by Zimmer Dental.
[175427759]
Zimmer biomet complaint (b)(4). Patient id and weight not provided/unknown. Device lot number not provided/unknown. Reporter's first name not provided/unknown. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[175427760]
It was reported that the hex tool and the implant would not disengage. The implant had to be removed and the procedure was completed with another implant and tool. Tooth location 19.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002023141-2020-00108 |
| MDR Report Key | 9597743 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-16 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-01-16 |
| 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 | 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 | RETAINING 2.5MM HEX DRIVE R LONG |
| Generic Name | DRIVER |
| Product Code | NDP |
| Date Received | 2020-01-16 |
| Catalog Number | RHL2.5 |
| 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 | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |