BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP, TSV, 4.7,10,MTX,MC,MG,HA

    MDR report key: 19563543 · Received June 18, 2024

    Report

    Report Number
    0002023141-2024-02038
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 17, 2024
    Report Date
    October 21, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344143
    PMA / PMN Number
    K101880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A2: AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED . G4: PMA/510(K) NUMBER K133339.

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVMWH10, (IMP, TSV, 4.7,10, MTX, MC, MG, HA) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICES IDENTIFIED THE IMPLANT AND BUNDLE MOUNT WITH SIGNS OF USE. THE RETURNED IMPLANT WAS OUTSIDE OF ITS SEALED PACKAGING. DURING PHYSICAL / FUNCTIONAL TESTING, THE MOUNT DID NOT DISENGAGE FROM THE IMPLANT AS INTENDED. THE COOB IS NON-VERIFIABLE AS THE CONDITION OF THE IMPLANT / PACKAGING WHEN RECEIVED BY THE CUSTOMER IS UNKNOWN / NON-VERIFIABLE. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1260891. 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 1260891 FOR SIMILAR EVENTS AND ONE (1) OTHER COMPLAINT WAS IDENTIFIED (B)(6). REVIEW COMPLETED UTILIZING KEYWORDS: ¿DOES NOT DISENGAGE/RELEASE¿ THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-00541-HAZ REV. 4, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE INCORRECT TECHNIQUES USED DURING IMPLANT PLACEMENT - CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, AND FUNCTIONAL TESTING A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT/COOB WAS NON-VERIFIABLE SINCE THE CONDITION OF THE PRODUCT/PACKAGING WHEN RECEIVED BY THE CUSTOMER WAS UNKNOWN / NON-VERIFIABLE. 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: CHANGED "NO" TO "YES" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MOUNT DID NOT COME OFF. AFTER THE IMPLANT WAS INSERTED, THE MOUNT AXIS COULD NOT BE REMOVED AND IT WAS REMOVED AND RE-IMPLANTED WITH THE SAME SIZE FROM STOCK. HE TRIED TO REMOVE IT AFTER THE SURGERY BUT IT WOULD NOT COME OFF. PROCEDURE COMPLETED WITH ANOTHER SAME SIZE

    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
    1123479 IMP, TSV, 4.7,10,MTX,MC,MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL 1260891 00889024344143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male