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 HEAL COLLAR 3.5X3.5, 5MM HC335 manufactured by Zimmer Dental.
[185193178]
Zimmer biomet complaint (b)(4). Patient age is not provided / unknown. Patient weight is not provided / unknown. Lot number is not provided / unknown. Initial reporter? S title and last name are not provided / unknown. The reported device was received for evaluation. The reported condition of healing collar could not seat in implant was not confirmed. Visual inspection of the as returned product identified signs of wear about the healing collar body and threads. Functional testing was performed for the returned product and it was determined that the healing collar seats as normal with a mating implant. Dhr review could not be performed, as the lot number associated with the reported product is not available. Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications. A complaint history review by item number was conducted dating back to 12 months from now. The complaint history review revealed that there are no existing non conformances/capa/hhe/d/ie/product holds for the reported product. A definitive root cause for the reported event could not be determined. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[185193179]
Doctor reports that healing cap hc335 was not able to be seated into the implant at tooth site #27.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002023141-2020-00646 |
| MDR Report Key | 9887694 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-03-16 |
| 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 | 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 3.5X3.5, 5MM |
| Generic Name | HEALING ABUTMENT |
| Product Code | NHA |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-06 |
| Catalog Number | HC335 |
| 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 | 2020-03-27 |