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 CERTAIN? UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (SHORT) IRE100U manufactured by Biomet 3i.
[184257929]
Zimmer biomet (b)(4). Age: not provided. Patient weight: not provided. Device lot number: not provided.
Patient Sequence No: 1, Text Type: N, H10
[184257930]
It was reported that during implant placement the driver (ire100u) became stuck in the implant. Procedure was completed using a different driver with a new implant. No injury to the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2020-00534 |
| MDR Report Key | 9856732 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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? UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (SHORT) |
| Generic Name | DENTAL EXTENSION IMPLANT DRIVER |
| Product Code | NDP |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-04 |
| Catalog Number | IRE100U |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-19 |