MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for HEAL COLLAR 4.5X4.5, 5MM HC445 manufactured by Zimmer Dental.
[185907731]
Zimmer biomet complaint number (b)(4). Patient identifier unknown / not provided. Age and date of birth unknown / not provided. Patient sex unknown / not provided. Weight unknown / not provided. Implant date unknown / not provided. Explant date unknown / not provided. Device manufacturer date number unknown / not provided.
Patient Sequence No: 1, Text Type: N, H10
[185907732]
It was reported that the healing abutment would not seat on the implant. They were able to complete the procedure with another same size healing abutment. Tooth location unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002023141-2020-00651 |
| MDR Report Key | 9886127 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-05 |
| 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 | 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 4.5X4.5, 5MM |
| Generic Name | HEALING COLLAR |
| Product Code | NHA |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-11 |
| Model Number | HC445 |
| Catalog Number | HC445 |
| Lot Number | 2018011539 |
| 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 | 2020-03-26 |