MAUDE Adverse Event Report: ZIMMER DENTAL ABUT CONTOUR 4.5X5.5 1MM CUFF; ABUTMENT

Model Number	ZOA451S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw loosened at the site.No additional information provided.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.Two abut contour 4.5x5.5 1mm cuff and retaining screws were returned for investigation.Visual evaluation of the as returned products identified no malfunction.However, the abutments were modified by the customer which is not considered a malfunction.Functional testing could not be performed since the products were modified.No pre-existing conditions were noted.The devices had been placed on tooth sites 46 and 47 for approximately 2 ½ years.X-ray & picture evaluation: x-ray or picture image was not provided.Review of appropriate documentation: documents reviewed: instructions for use : abutments and restorative components for trabecular metal, tapered screw-vent, and screw-vent implant systems ¿ ifu9664 rev 3 ¿ 11/19.Information identified: contraindications & precautions.Per the applicable ifu, 'implant and abutment fractures can occur when applied loads exceed the normal functional design tolerances of the implant components'.Dhr review: dhr review for the lot (2019061151) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2019061151) for similar events (complaint category keywords: loosening) and 1 other complaint was identified.Post market trending review: september post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur.However, the reported event (loosening) could not be verified as the exact details of event were unverifiable.

• Brand Name: ABUT CONTOUR 4.5X5.5 1MM CUFF
• Common Device Name: 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: 15085395
• Report Number: 0002023141-2022-01858
• Device Sequence Number: 14461811
• Product Code: NHA
• UDI-Device Identifier: 00889024020825
• UDI-Public: (01)00889024020825(17)240624(10)2019061151
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 12/09/2022

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: 06/24/2024
• Device Model Number: ZOA451S
• Device Catalogue Number: ZOA451S
• Device Lot Number: 2019061151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• 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: 07/05/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2019
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 65 KG