BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 23783458 · Received December 11, 2025

    Report

    Report Number
    0001038806-2025-03791
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Report Date
    February 2, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019997
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    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 CODE WAS ADDED: 10, 4109, 3331 AND 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 180. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 4307. H10: NARRATIVE/DATA WAS UPDATED. ZIMVIE RECEIVED THE REPORTED DEVICE FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICES IDENTIFIED THE IMPLANT, AND BUNDLE MOUNT WITH SIGNS OF USE, DEBRIS, AND MINOR APPARENT BONE / TISSUE ATTACHED TO THE IMPLANT'S EXTERNAL THREADS. THE IMPLANT AND MOUNT WERE OBSERVED ATTACHED TOGETHER, AND DURING A PHYSICAL / FUNCTIONAL TEST THE IMPLANT AND MOUNT DID NOT DISENGAGE/RELEASE AS INTENDED. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. 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 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS INCORRECT TECHNIQUE USED DURING IMPLANT PLACEMENT - CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER ¿ K101880. PRODUCT HAS BEEN RECEIVED BY ZIMVIE 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 THE IMPLANT ANALOG AND OR CARRIER WAS INITIALLY LOOSENED FROM THE IMPLANT PRIOR TO PLACEMENT, HOWEVER IT BECAME FUSED DURING PLACEMENT. IT WAS CONFIRMED THAT ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413720 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1289716 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male