MAUDE Adverse Event Report: ZIMMER DENTAL ABUT GOLD FRICTION-FIT 4. 5MM IMP; DENTAL ABUTMENT

Model Number	HLA4G
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that due to too little friction with the hexagon the abutment came loose.Tooth site 14.Procedure was completed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Premarket identification k013227 and k953101.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One (1) abut gold friction-fit 4.5mm imp (hla4g) was returned for investigation.Visual evaluation of the as returned products identified signs of use but no damage/malfunction.Functional testing was performed and the abutment engaged/seated/retained as intended with in-house implant.No pre-existing conditions were noted.The device had been placed on tooth site #14 (unknown dental notation system) for an unknown period of time.Dhr review was completed for the subject lot number 63764543.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, were 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 number 63764543 for similar events and no other complaint was identified.Review completed utilizing keywords: functional : loosening therefore, based on the available information, device malfunction has not occurred and 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 GOLD FRICTION-FIT 4. 5MM IMP
• 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: 15907713
• Report Number: 0002023141-2022-03001
• Device Sequence Number: 6096888
• Product Code: DZE
• UDI-Device Identifier: 00889024015234
• UDI-Public: (01)00889024015234(10)63764543
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K011028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: Lay User/Patient
• Device Model Number: HLA4G
• Device Catalogue Number: HLA4G
• Device Lot Number: 63764543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/09/2022
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2017
• 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
• Patient Sex: Female