MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-19 for XFR HEX INDIRECT SCR-V 4. 5MM IMP 4.5MM FLARE HLT4/4 manufactured by Zimmer Dental.
[184269937]
Zimmer biomet complaint number (b)(4). Date of birth unknown / not provided. Weight unknown / not provided. Lot number unknown / not provided. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[184269938]
It was reported that the screw fractured inside the implant. Tooth location 14.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002023141-2020-00598 |
| MDR Report Key | 9853762 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-19 |
| 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 | XFR HEX INDIRECT SCR-V 4. 5MM IMP 4.5MM FLARE |
| Generic Name | SCREW |
| Product Code | NDP |
| Date Received | 2020-03-19 |
| Catalog Number | HLT4/4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-19 |