MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-30 for HEALING ABUTMENT manufactured by Zimmer Dental.
[177163065]
Zimmer biomet complaint (b)(4). Patient weight: not provided. Device brand name: not provided. Device product code: not provided. Device catalog/ lot number: not provided. Pma/510(k) number: not provided.
Patient Sequence No: 1, Text Type: N, H10
[177163066]
It was reported that an unknown healing abutment was unable to be removed from the implant. Event occurred after two weeks of implant placement. Doctor wait another two weeks to allow implant to heal and healing abutment was unable to be removed. As a result, implant was removed. Another implant was placed. Tooth location 9.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002023141-2020-00193 |
| MDR Report Key | 9649553 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-01-30 |
| 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 | ZIMMER DENTAL |
| 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 |
| Generic Name | HEALING ABUTMENT |
| Product Code | DZA |
| Date Received | 2020-01-30 |
| Returned To Mfg | 2020-01-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER DENTAL |
| Manufacturer Address | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-30 |