MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X4.5, 5MM; HEALING COLLAR

Model Number	HC445
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
One healing collar was returned for investigation, see attached images a122 and a123 in the complaint.Visual inspection of the as returned product identified no damage.Functional testing was performed for the returned product with an in-house stock device and is confirmed that it does seat correctly.No pre-existing conditions were noted on the per.The reported device tooth location and length of implantation of use is unknown.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number for similar event and no other complaint was identified.Based on the available information, device malfunction did not occur and the reported event was unconfirmed.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HEAL COLLAR 4.5X4.5, 5MM
• Common Device Name: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9886127
• Report Number: 0002023141-2020-00651
• Device Sequence Number: 2750721
• Product Code: NHA
• UDI-Device Identifier: 00889024015050
• UDI-Public: (01)00889024015050(17)230122(10)2018011539(241)HC445
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: HC445
• Device Catalogue Number: HC445
• Device Lot Number: 2018011539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention