MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X4.5, 3MM; HEALING ABUTMENT

Model Number	HC443
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient's weight not provided.
Event or Problem Description
It was reported that during the final rotation the final abutment could not be seated.Tooth #19.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
One heal collar 4.5x4.5, 3mm (hc443) was returned for investigation.Visual evaluation of the as returned product indicated significant signs of use.Abutment screw thread identified stripped.Functional testing was performed for the returned products and the device could not seat as intended.Patient pre-existing condition is patient having high (type i) bone density.Tooth location is #19 (universal).Dhr review (hc443): dhr review was completed for the subject lot number 2019090758.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 (hc443): complaint history review by lot number (2019090758) was performed for similar events and 1 other similar complaint was identified for item: hc443 which is (b)(4).Post market trending review: monthly post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not seat) or product (hc443).Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: HEAL COLLAR 4.5X4.5, 3MM
• Common Device Name: HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11358954
• Report Number: 0002023141-2021-00443
• Device Sequence Number: 3416536
• Product Code: NHA
• UDI-Device Identifier: 00889024015043
• UDI-Public: (01)00889024015043(17)240915(10)2019090758(241)HC443
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 06/10/2021

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: 09/15/2024
• Device Model Number: HC443
• Device Catalogue Number: HC443
• Device Lot Number: 2019090758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR