MAUDE Adverse Event Report: ZIMMER DENTAL ABUT CONTOUR 4.5X4.5 1MM CUFF; DENTAL ABUTMENT

Model Number	ZOA441S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Weight unknown / not provided.Email address was not provided.
Event or Problem Description
Doctor reported loosening of abutment zoa441s at tooth side 36 twice.A new screw and a new crown have been used to complete the procedure.
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 screw-replace friction-fit gold (mhlas) was returned for investigation.The reported/associated abutment (zoa441s) was not returned.Visual evaluation of the as returned product identified signs of wear due to usage.The device was in good condition.Per complaint description the device had loosened twice.This investigation was focused on the second loosening event.Functional testing could not be performed due to the nature of the device and event.No pre-existing conditions were noted.The reported devices were placed on tooth # 36 (fdi) for approximately 2 years.Picture or x-ray images were not provided.Device history record (dhr) review was completed for the subject lot number (2018071880).It was confirmed that all operations and inspections were executed as per applicable procedures.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 completed for the subject lot number (2018071880).No other complaints about nonconforming products were identified.Based on the available information device malfunction and the reported event could not be verified since the abutment was not returned.Additionally, no malfunction was identified with the screw.

• Brand Name: ABUT CONTOUR 4.5X4.5 1MM CUFF
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10249554
• Report Number: 0002023141-2020-01028
• Device Sequence Number: 3106855
• Product Code: NHA
• UDI-Device Identifier: 00889024020771
• UDI-Public: (01)00889024020771(17)230724(10)2018071880(241)ZOA441S
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/30/2020

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: Lay User/Patient
• Device Expiration Date: 07/24/2023
• Device Model Number: ZOA441S
• Device Catalogue Number: ZOA441S
• Device Lot Number: 2018071880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1