MAUDE Adverse Event Report: ZIMMER DENTAL 15 DEG TAPER 3.5P,1MM-2MM; DENTAL ABUTMENT

Model Number	15AT312
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the abutment was loose.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).One 15 deg taper 3.5p,1mm-2mm (15at312) and one 15 deg taper,3.5p 2mm-3mm (15at323) were returned for investigation.Visual evaluation of the as returned products identified no apparent malfunction, signs of use with blood and debris on the devices.Functional testing to recreate the reported event could not be performed due to the nature of the devices & event.Device history record (dhr) reviews were completed for the subject lot numbers (63808228 & 63650221).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 dhrs.Lots were inspected and passed all acceptance criteria by qa.Complaint history reviews were performed for the reported lot numbers (63808228 & 63650221) for similar events and no other complaint was identified.Complaint category keyword: loosening therefore, based on the available information, device malfunction did not occur and the reported event was non-verifiable for the reported devices.

• Brand Name: 15 DEG TAPER 3.5P,1MM-2MM
• 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: 12133542
• Report Number: 0002023141-2021-01719
• Device Sequence Number: 19866279
• Product Code: NHA
• UDI-Device Identifier: 00889024012035
• UDI-Public: (01)00889024012035(17)221031(10)83808228
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K111853
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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 Expiration Date: 10/31/2022
• Device Model Number: 15AT312
• Device Catalogue Number: 15AT312
• Device Lot Number: 63808228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• 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: 06/15/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2017
• 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 Age: 68 YR
• Patient Sex: Unknown