MAUDE Adverse Event Report: ZIMMER DENTAL ABUT GOLD FRICTION-FIT 3. 5MM IMP; DENTAL ABUTMENT

Model Number	HLA3G
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number cmp-(b)(4).Patient weight unknown / not provided.Device expiration date unknown / not provided.Pma/510(k) number: k013227, k953101.
Event or Problem Description
It was reported that at tooth location #12 - loose abutment & screw to replace / crown and implant body were fine.Patient returning for additional appointment to place encode & scan.As a result of this event, no injury to the patient was reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One abut gold friction-fit 3.5mm imp (hla3g) and one coping gold eng 5.7 mm im p (hla5g) were reported but not returned for investigation.Therefore, visual evaluation could not be performed.The returned mhlas screw has been moved to associated item and per customer, there were no allegations against it.The investigation was performed using applicable instructions for use (ifus), risk files and other available information.Functional testing could not be performed since the products were not returned.No pre-existing conditions were noted.The reported devices had been placed on tooth # 3 & 12 for approximately 2 years.Picture or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review for the lots (63838269 & 2018020402) had revealed no deviations nor non-conformance's which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (63838269 & 2018020402) for similar events and no other complaint was identified.Based on the available information, device malfunction and the reported event could not be verified since the products were not returned.

• Brand Name: ABUT GOLD FRICTION-FIT 3. 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: 12226548
• Report Number: 0002023141-2021-01919
• Device Sequence Number: 1323195
• Product Code: DZE
• UDI-Device Identifier: 00889024015197
• UDI-Public: (01)00889024015197(17)991231(10)2018020402
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

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: Lay User/Patient
• Device Model Number: HLA3G
• Device Catalogue Number: HLA3G
• Device Lot Number: 2018020402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• 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: 07/06/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male