MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X4.5, 3MM; HEALING COLLAR

Model Number	HC343
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that the healing abutment was placed (b)(6) 2020 and loosened requiring it to be retightened on (b)(6) 2020.Patient was sent home.Tooth location unknown.
Additional Manufacturer Narrative
One healing collar (hc343) was returned for investigation (images 1 & 3).Visual evaluation of the as returned product identified minor signs of wear due to usage.The device had no apparent malfunction.Two loosening events were reported with the device.This investigation addresses the first loosening event.Functional testing was performed using applicable in-house implant; the implant was able to engage and disengage with the healing collar as normal (image 2).No pre-existing conditions were reported.The device had been placed on an unknown tooth location for approximately 1 month when the incident occurred.X-ray or picture images were not provided and no other information was provided.Appropriate documentation was removed.Dhr review for the lot (2019060895) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the lot (2019060895) for similar events and one other complaint was identified ¿ (b)(4).Based on the available information and functional testing, device malfunction did not occur.However, the reported event could not be verified as the exact details of event were non-verifiable.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HEAL COLLAR 3.5X4.5, 3MM
• Common Device Name: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10829014
• Report Number: 0002023141-2020-01942
• Device Sequence Number: 4135568
• Product Code: NHA
• UDI-Device Identifier: 00889024014992
• UDI-Public: (01)00889024014992(17)240617(10)2019060895(241)HC343
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: Lay User/Patient
• Device Expiration Date: 06/16/2024
• Device Model Number: HC343
• Device Catalogue Number: HC343
• Device Lot Number: 2019060895
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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