MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-03 for HEAL COLLAR 3.5X4.5, 3MM HC343 manufactured by Zimmer Dental.
[181997901]
Zimmer biomet complaint (b)(4). Patient weight not provided/unknown.
Patient Sequence No: 1, Text Type: N, H10
[181997902]
It was reported that during the placement procedure, the healing abutment became stuck in the implant and would not disengage. The implant was removed and another one was placed during the same procedure. Tooth location 8.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002023141-2020-00475 |
| MDR Report Key | 9781869 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2018-01-09 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| Brand Name | HEAL COLLAR 3.5X4.5, 3MM |
| Generic Name | HEALING COLLAR |
| Product Code | NHA |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-02-18 |
| Catalog Number | HC343 |
| Lot Number | 2018010400 |
| 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 | 2020-03-03 |