MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-26 for HEAL COLLAR 3.5X5.5, 5MM HC355 manufactured by Zimmer Dental.
[185907929]
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. Title unknown/ not provided.
Patient Sequence No: 1, Text Type: N, H10
[185907930]
It was reported that the doctor was not able to screw the healing collar to the implant. Doctor completed the procedure using another healing collar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002023141-2020-00635 |
| MDR Report Key | 9882007 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2017-09-26 |
| 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 | 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 3.5X5.5, 5MM |
| Generic Name | HEALING ABUTMENT |
| Product Code | NHA |
| Date Received | 2020-03-26 |
| Model Number | HC355 |
| Catalog Number | HC355 |
| Lot Number | 2017091496 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |