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 2020-02-07 for DO NOT UE-CERTAIN? RATCHET EXTENSION - SHORT 4.1, 5.0, 6.0MM(D) IRE100 manufactured by Biomet 3i.
[178155405]
Zimmer biomet (b)(4). Patient identifier unknown / not provided. Age and date of birth unknown / not provided. Weight unknown / not provided. Lot number unknown / not provided.
Patient Sequence No: 1, Text Type: N, H10
[178155406]
It was reported that the internal threads of the implant were damaged during tightening with the ratchet extension. The implant was removed and replaced with another implant. Tooth location 36.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2020-00289 |
| MDR Report Key | 9681581 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-07 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-11-04 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-02-07 |
| 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 | DO NOT UE-CERTAIN? RATCHET EXTENSION - SHORT 4.1, 5.0, 6.0MM(D) |
| Generic Name | RATCHET EXTENSION |
| Product Code | NDP |
| Date Received | 2020-02-07 |
| Catalog Number | IRE100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-07 |