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

Model Number	HC455
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Customer reported that the healing abutment did not seat in the implant.They were able to complete the procedure with another healing abutment.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: type of investigation codes were added: 4109, 4111, 4114, 4110 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67.The heal collar 4.5x5.5, 5mm (hc455) was not returned for investigation.Since product has not been returned, visual/functional inspection could not be performed.Functional testing to recreate the reported event could not be as the device was not returned.Patient pre-existing condition, tooth location and duration of implant are unknown due to limited information provided by customer.The customer has not provided additional pictures or x-ray images of the product.Dhr review was completed for the subject lot number 63344258.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 (63344258) using keyword (does not seat) and no other complaint was found.October post market trending was reviewed and there were no actionable events or corrective actions for the reported events or product (hc455).Therefore, based on the available information, device malfunction and the reported event could not be verified as the exact details of event were non-verifiable and the product was not returned.

• Brand Name: HEAL COLLAR 4.5X5.5, 5MM
• Common Device Name: DENTAL ABUTMENT
• 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: 12295970
• Report Number: 0002023141-2021-02068
• Device Sequence Number: 4724850
• Product Code: NHA
• UDI-Device Identifier: 00889024015074
• UDI-Public: (01)00889024015074(17)210430(10)63344258
• 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,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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 Expiration Date: 04/30/2021
• Device Model Number: HC455
• Device Catalogue Number: HC455
• Device Lot Number: 63344258
• Was Device Available for Evaluation?: No
• 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: 07/19/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2016
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT; DENTAL IMPLANT
• Patient Sex: Unknown