BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,11.5

    MDR report key: 17071694 · Received June 6, 2023

    Report

    Report Number
    0002023141-2023-01585
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    May 3, 2023
    Report Date
    December 4, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019232
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSV4B11, (IMP,TSV,4.1MM,SBM,11.5) AND ONE (1) UNKNOWN ABUTMENT / CROWN FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, NO DAMAGE TO THE ABUTMENT/CROWN WAS IDENTIFIED. THE IMPLANT WAS FRACTURED WITH AN UNKNOWN REMOVAL TOOL STUCK INSIDE. NOTE, THE REMOVAL TOOL DIDN¿T CONTRIBUTE TO THIS EVENT. THIS COMPLAINT REFERS TO THE TSV4B11. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1222216. 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 1222216 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : FUNCTIONAL : FRACTURE : IMPLANT¿ THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RM-00541-HAZ, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS THE MATERIAL SELECTION OF IMPLANT INADEQUATE (UNABLE TO WITHSTAND OCCLUSAL FORCES OR LONG TERM LOADING). THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE IMPLANTS COLLAR WAS FRACTURED. THE REPORTED EVENT WAS CONFIRMED. 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. 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 HEX OF IMPLANT CRACKED, CAUSING FAILURE OF ABUTMENT AND CROWN. SYMPTOMS AS A RESULT OF THE EVENT: NONE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735835 IMP,TSV,4.1MM,SBM,11.5 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B11 1222216 00889024019232

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Prefer Not To Disclose Required Intervention