MAUDE Adverse Event Report: ZIMMER DENTAL ABUT,HEX-LOCK,CONT,3.5X4.; DENTAL ABUTMENT

Catalog Number	ZOA341A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reported that the abutment loosened abnormally, the affected dental position is 14.The doctor indicates that the procedure was not concluded by placing another abutment.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) zoa341a, (abut, hex-lock, cont, 3.5x4.) for evaluation.A visual evaluation was performed, and signs of use was identified, no signs of malfunction.Dhr review was completed for the subject lot number 63773380.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 63773380 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : loosening.Based on the investigation and risk management file review, the most likely root cause(s) determined from the investigation was the abutment not seated properly, improper screw placement.Therefore, based on the available information, a device malfunction could not be verified.The abutment exhibited signs of use but no apparent malfunction.The reported event was non-verifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: ABUT,HEX-LOCK,CONT,3.5X4.
• 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: 16768467
• Report Number: 0001038806-2023-00776
• Device Sequence Number: 3251808
• Product Code: NHA
• UDI-Device Identifier: 00889024020719
• UDI-Public: (01)00889024020719(17)220831(10)63773380
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K052600
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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: Other
• Device Expiration Date: 08/30/2022
• Device Catalogue Number: ZOA341A
• Device Lot Number: 63773380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 47 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic