BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,DUAL SEL,HA

    MDR report key: 19713152 · Received July 10, 2024

    Report

    Report Number
    0002023141-2024-02312
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 12, 2024
    Report Date
    September 26, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019300
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). IT WAS REPORTED THAT THE INTERNAL HEX WAS BROKEN AND IMPLANT AT TOOTH SITE 36 HAD TO BE REMOVED WITH A TREPHINE DRILL. BONE DENSITY WAS TYPE II BONE DENSITY. PATIENT HISTORY WAS UNKNOWN. THE SITE WAS GRAFTED. ZIMVIE RECEIVED ONE (1) TSV4H10, (IMP, TSV, 4.1MM, DUAL SEL, HA) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THE IMPLANT HAD SIGNS OF USE WITH BONE DEBRIS ON ITS EXTERNAL THREADS. THE IMPLANT WAS FRACTURED AT THE COLLAR. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1243776. 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 1243776 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL; FUNCTIONAL; FRACTURE; IMPLANT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE IMPLANT WAS FRACTURED AT THE COLLAR. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT THE INTERNAL HEX WAS BROKEN AND IMPLANT AT TOOTH SITE 36 HAD TO BE REMOVED WITH A TREPHINE DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363136 IMP,TSV,4.1MM,DUAL SEL,HA DENTAL IMPLANT DZE ZIMMER DENTAL 1243776 00889024019300

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female