MAUDE Adverse Event Report: ZIMMER DENTAL ABUT CONTOUR 3.5X4.5 3MM CUFF; DENTAL ABUTMENT

Model Number	ZOA343S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Weight unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported that the screw abutment lost ist pull out resistance.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp-(b)(4).One abut contour 3.5x4.5 3mm cuff (zoa343s) was not returned for investigation.However, one retaining screw (mhlas) was returned.Visual evaluation of the as returned product identified signs of use and screw was identified deformed.No pre-existing conditions were noted.The device had been placed on tooth location 36 (fdi) for the duration of approximately 3 months.X-ray or picture images were 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 ifu 9664 rev 3 - (b)(6) 2019 information identified: warnings, precautions and potential adverse events.Per the applicable ifu, under section "precautions", it is stated that improper technique could cause screw loosening.Dhr review was completed for the subject lot number 63836216.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 (63836216) for similar event and no other complaint was identified.Monthly post market trending was reviewed and there were no actionable events or corrective actions for the reported event (functional: loosening) or products.Based on the available information device malfunction and the reported event could not be verified since the abutment was not returned.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).

• Brand Name: ABUT CONTOUR 3.5X4.5 3MM CUFF
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11076621
• Report Number: 0002023141-2020-02395
• Device Sequence Number: 3561932
• Product Code: NHA
• UDI-Device Identifier: 00889024020757
• UDI-Public: (01)00889024020757(17)221031(10)63836216(241)ZOA343S
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K052600
• 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,Followup
• Report Date (Section B): 03/25/2021

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: ZOA343S
• Device Catalogue Number: ZOA343S
• Device Lot Number: 63836216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 03/02/2021; 03/24/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 03/16/2021; 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR