BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABUT HEX-LOCK 3.5MM IMP 5 .5 FLARE

    MDR report key: 19864032 · Received July 30, 2024

    Report

    Report Number
    0002023141-2024-02604
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    June 15, 2024
    Report Date
    December 15, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). D10: TSV4B10, IMP,TSV,4.1MM,SBM,10, LOT NUMBER 63845302. E1: INITIAL REPORTER¿S TITLE IS NOT PROVIDED/UNKNOWN. G4: ADDITIONAL 510(K) NUMBERS ARE K013227 AND K953101.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D4: ADDITIONAL DEVICE INFORMATION. D9: DEVICE AVAILABILITY. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H4: DEVICE MANUFACTURER DATE. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. ZIMVIE RECEIVED ONE (1) HLA3/5, (ABUT HEX-LOCK 3.5MM IMP 5 .5 FLARE) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE ABUTMENT WITH SIGNS OF USE, AND WAS ATTACHED TO A CROWN. THE RETURNED SCREW WAS OBSERVED FRACTURED AT THE THREADS REGION. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2020030431. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 2020030431 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE SCREW. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE CLINICIAN ERROR, OR PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXAMINATION REVEALED A BROKEN ABUTMENT SCREW AND A LOOSE IMPLANT, AND THE IMPLANT AND ABUTMENT WERE REMOVED. TOOTH SITE #13 FDI.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208230 ABUT HEX-LOCK 3.5MM IMP 5 .5 FLARE DENTAL ABUTMENT DZE ZIMMER DENTAL 2020030431

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention DENTAL IMPLANT, SEE H10 NARRATIVE.| DENTAL IMPLANT, SEE H10 NARRATIVE.