MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X5.5, 3MM; DENTAL HEALING COLLAR

Model Number	HC345
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the healing collar didn't engage to the implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
Hc453 - dental: functional: disengaged, does not seat.
Additional Manufacturer Narrative
One (1) heal collar 4.5x5.5, 3mm (hc453) was returned for investigation.Visual evaluation of the as returned product identified the healing collar with signs of use.The reported item hc345 does not match the actual product returned.During measurements using caliper 05593632, due june 07, 2023, the healing collar was identified as hc453.Functional testing with an in-house implant to recreate the reported event; verified no malfunction.No pre-existing condition noted, and no per form was provided.Bone density type is unknown.The reported device was located on a tooth site (universal).The length of the device usage is unknown.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review and complaint history review by lot number 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 for the (hc453) dating back to 12 months prior to the notification date.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.September post market trending was reviewed and there were no actionable events or corrective actions for the reported events.No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did not occur, and the reported events are non-verifiable, with the information provided.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: HEAL COLLAR 4.5X5.5, 3MM
• Common Device Name: DENTAL HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 14570717
• Report Number: 0002023141-2022-01344
• Device Sequence Number: 14718750
• Product Code: NHA
• UDI-Device Identifier: 00889024015005
• UDI-Public: (01)00889024015005(17)250302(10)2020021877
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2022

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: 03/02/2025
• Device Model Number: HC345
• Device Catalogue Number: HC453
• Device Lot Number: 2020021877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 09/12/2022; 11/10/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 09/14/2022; 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose