MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 5.7X6.5, 3MM; HEALING ABUTMENT

Catalog Number	HC563
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp-(b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Lot number and unique identifier (udi) number unknown / not provided.
Event or Problem Description
It was reported that the healing collar could not be removed from the implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4) the reported device was not returned for investigation.Since product has not been returned, visual/functional inspection could not be performed.No pre-existing conditions were noted on the product experience report.The reported healing collar was located on tooth # 19 and was removed after an unknown period of time.The reported event could not be recreated without return of the device for testing.The customer has not provided x-ray or pictures to aid the evaluation.Device history record (dhr) review could not be performed, as the lot number associated with the reported product was not made available.However, 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 dating back to 12 months.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product.Complainant reported that the healing collar could not be removed from the implant.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.

• Brand Name: HEAL COLLAR 5.7X6.5, 3MM
• Common Device Name: HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11719441
• Report Number: 0002023141-2021-01045
• Device Sequence Number: 11021593
• Product Code: NHA
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 09/01/2021

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: Health Professional
• Device Catalogue Number: HC563
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1