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 2020-03-11 for CERTAIN? TITANIUM HEXED SCREW UNKNOWN BIOMET SCREW manufactured by Biomet 3i.
[187902872]
Zimmer biomet complaint number (b)(4). Age and date of birth unknown / not provided. Weight unknown / not provided. Additional device information unknown / not provided. Device manufacturer date unknown / not provided. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[187902873]
It was reported that the patient came to medical center due to crown loosening and mobility of implant. When checking the implant, doctor noticed that the internal implant hex was damaged and the screw was loose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2020-00485 |
| MDR Report Key | 9816990 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-11 |
| 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? TITANIUM HEXED SCREW |
| Generic Name | DENTAL SCREW |
| Product Code | NHA |
| Date Received | 2020-03-11 |
| Catalog Number | UNKNOWN BIOMET SCREW |
| Lot Number | UNKNOWN |
| 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 | 1. Required No Informationntervention | 2020-03-11 |