MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-04 for CERTAIN? GOLD-TITE? HEXED SCREW IUNIHG manufactured by Biomet 3i.
[182134519]
Zimmer biomet (b)(4). Age: not provided. Initial reporter fax number: not provided. Device was not returned
Patient Sequence No: 1, Text Type: N, H10
[182134520]
It was reported that abutment screw (iunihg) fractured within the implant during crown loading at tooth location 19. All fractured parts were removed and implant remains intact. Another abutment was placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2020-00466 |
| MDR Report Key | 9788240 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-04 |
| 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 | BIOMET 3I |
| 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 | CERTAIN? GOLD-TITE? HEXED SCREW |
| Generic Name | DENTAL SCREW |
| Product Code | NHA |
| Date Received | 2020-03-04 |
| Catalog Number | IUNIHG |
| Lot Number | 1186478 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET 3I |
| Manufacturer Address | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |