MAUDE Adverse Event Report: ZIMMER DENTAL ABUT CONTOUR 3.5X4.5 1MM CUFF; DENTAL ABUTMENT

Model Number	ZOA341S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that the abutment screw loosening.Screw removed and replaced.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The abut contour 3.5x4.5 1mm cuff (zoa341s) was not returned.Since product has not been returned, visual/functional evaluation could not be performed.The investigation has been performed based on the available information.No pre-existing conditions were noted on the per.The reported product was located on an unknown tooth site and used for approximately 7 years.The reported event could not be recreated due to the nature of the dental device and event (loosening).Device history review (dhr) review was completed for the subject lot number 62428694.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 was 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 (62428694) for similar event and no other complaint was identified.Therefore, based on the available information, device malfunction could not be verified 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 CONTOUR 3.5X4.5 1MM CUFF
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10361197
• Report Number: 0002023141-2020-01178
• Device Sequence Number: 19698841
• Product Code: NHA
• UDI-Device Identifier: 00889024020726
• UDI-Public: (01)00889024020726(17)180731(10)62428694(241)ZOA341S
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052600
• 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): 10/28/2020

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: 07/31/2018
• Device Model Number: ZOA341S
• Device Catalogue Number: ZOA341S
• Device Lot Number: 62428694
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR