MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for CERTAIN? GOLD-TITE? HEXED SCREW IUNIHG manufactured by Biomet 3i.
[186751118]
Zimmer biomet complaint number (b)(4). Device manufacturer date unknown/not provided. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[186751119]
It was reported that a screw fractured in the patient mouth and part of it is still stuck in the implant. The top portion of screw for site 19 was discarded. Surgeon has discarded bottom portion as well. They noted that the gums had already grown over implant by the time the surgeon worked on screw removal. Overgrowth had to be removed and sutured prior to removal. Screw was removed and needs custom abutment at this point.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2020-00584 |
| MDR Report Key | 9889846 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Catalog Number | IUNIHG |
| Operator | LAY USER/PATIENT |
| 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 | 2020-03-27 |