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 BELLATEK? ENCODE? HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 8MM(H) EHA558 manufactured by Biomet 3i.
[185548525]
Zimmer biomet (b)(4). Patient weight: not provided. Event date: not provided. Initial reporter fax number: not provided. This event is related to (b)(4) mfr# 0001038806 - 2020 - 00586. Device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[185548526]
It was reported that a healing abutment (eha558) could not seat into the implant. Prior to this event, doctor forced a different healing abutment down into the same implant (see (b)(4) mfr# 0001038806 - 2020 - 00586). Doctor removed the healing abutment from previous event and a new healing abutment (eha558) was attempted to seat into the implant. Finally, doctor decided to removed this healing abutment and the previous healing abutment was repositioned back into the implant. Implant remains implanted. Tooth location 14.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001038806-2020-00588 |
| MDR Report Key | 9890637 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2016-03-09 |
| 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 | 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 | BELLATEK? ENCODE? HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 8MM(H) |
| Generic Name | HEALING ABUTMENT |
| Product Code | NHA |
| Date Received | 2020-03-27 |
| Catalog Number | EHA558 |
| Lot Number | 1192734D |
| 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 | 2020-03-27 |