BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

    MDR report key: 19522284 · Received June 12, 2024

    Report

    Report Number
    0002023141-2024-01946
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 8, 2024
    Report Date
    October 22, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020054
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODES WERE ADDED: 4109, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 67. H10: NARRATIVE/DATA WAS UPDATED. ZIMVIE RECEIVED THE REPORTED IMPLANT FOR EVALUATION. VISUAL EVALUATION / FUNCTIONAL TEST WAS PERFORMED AND COVER SCREW DETACHED FROM IMPLANT AS INTENDED. DAMAGED DUE TO THE REMOVAL PROCESS. NO MALFUNCTION IDENTIFIED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1231838. 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 1231838 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL: FUNCTIONAL: DOES NOT DISENGAGE/RELEASE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE DEVICE MALFUNCTION DID NOT OCCUR, AND THE REPORTED EVENT HAS BEEN UNCONFIRMED FOLLOWING FUNCTIONAL TESTING AND PHYSICAL EVALUATION. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR. NO MALFUNCTION DISCOVERED. IMPLANT DETACHED FROM MOUNT AS INTENDED. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN / NOT PROVIDED G4: ADDITIONAL PMA/510(K) NUMBER ¿ K013227 PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON THE TORQUE TEST APPOINTMENT FOR THE IMPLANT AT TOOTH SITE #20, THE IMPLANT PASSED TEST BUT THE COVER SCREW WAS COLD WELDED. THE IMPLANT STARTED TO TURN WHEN THEY TRIED TO REMOVE THE SCREW. THE CLINICIAN HAD TO EXTRACT THE IMPLANT AND REPLACE IT WITH A NEW ONE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182522 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1231838 00889024020054

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male