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

Model Number	HC445
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided weight unknown / not provided.First/given name: unknown / not provided.Email address unknown / not provided.
Event or Problem Description
Doctor indicated that it was impossible to screw the healing collar.Procedure was completed with another abutment.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One healing collar (hc445) was returned for investigation.Visual evaluation of the as returned product identified damaged threads and signs of wear.Functional testing was performed using an in-house implant.The device could not seat on the implant because the threads were damaged.Pre-existing patient factors, implant age, tooth location are not relevant to the reported event.Doctor was attempting to place the device on an unknown tooth location when the incident occurred.X-ray or picture images were not provided and no other information was provided.Dhr review for the lot (2019030801) 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 (2019030801) for similar event and no other complaint was identified.Therefore, based on the available information and functional testing, device malfunction has occurred and the reported event was confirmed.

• Brand Name: HEAL COLLAR 4.5X4.5, 5MM
• Common Device Name: DENTAL HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9646695
• Report Number: 0002023141-2020-00183
• Device Sequence Number: 3414799
• Product Code: NHA
• UDI-Device Identifier: 00889024015050
• UDI-Public: (01)00889024015050(17)240312(10)2019030801(241)HC445
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 03/12/2024
• Device Model Number: HC445
• Device Catalogue Number: HC445
• Device Lot Number: 2019030801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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