MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for CERTAIN? BELLATEK? ENCODE? HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) IEHA464 manufactured by Biomet 3i.
[188659993]
Zimmer biomet (b)(4). Patient weight not provided/unknown. Reporter's email not provided/unknown.
Patient Sequence No: 1, Text Type: N, H10
[188659994]
It was reported that the abutment screw fractured in the implant. The implant had to be removed. Tooth location 4.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2020-00577 |
| MDR Report Key | 9885361 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-04-19 |
| Date Added to Maude | 2020-03-26 |
| 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? BELLATEK? ENCODE? HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) |
| Generic Name | ABUTMENT |
| Product Code | NHA |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-02 |
| Catalog Number | IEHA464 |
| Lot Number | 1215481 |
| Operator | LAY USER/PATIENT |
| 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 | 1. Required No Informationntervention | 2020-03-26 |