BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 8 MM

    MDR report key: 23361467 · Received October 22, 2025

    Report

    Report Number
    0001038806-2025-02642
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024013162
    PMA / PMN Number
    K013494
    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). G4: ADDITIONAL PMA/510(K) NUMBER K962106.

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) 1993, (IMPL TWIST MP-1 5.0 MM 8 MM) FOR EVALUATION. VISUAL EVALUATION / FUNCTIONAL TEST WAS PERFORMED; IMPLANT SHOWS SLIGHT WEAR AND TESTING SHOWS AN IN-HOUSE COVER SCREW DOES NOT FIT/THREAD INTO THE IMPLANT. INTERNAL THREADS ARE DAMAGED. MALFUNCTION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: 2022020226. NO DEVIATIONS OR NON-CONFORMANCE'S, 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: 2022020226 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 AS PER RM-002J2, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS CLINICIAN USES DEVICE IMPROPERLY, INSUFFICIENT TRAINING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE INTERNAL THREADS ARE DAMAGE AND DOES NOT ALLOW IN-HOUSE COVER SCREW TO FIT INSIDE IMPLANT. THE REPORTED EVENT IS 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D9: DEVICE AVAILABILITY. 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 THE HEALING CAP WON'T FIT. AFTER PLACING SPLINE 1993, ATTEMPTED TO FIT A GINGIVAL CUFF (PRODUCT NUMBER UNKNOWN) BUT IT DID NOT FIT. ANOTHER GINGIVAL CUFF ALSO DID NOT FIT, SO SPLINE 1993 WAS REPLACED. THE PHYSICIAN SUSPECTS THE FIXTURE'S SCREW THREADS. REPLACEMENT WITH EQUIVALENT PRODUCT COMPLETED.

    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
    15291 IMPL TWIST MP-1 5.0 MM 8 MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 2022020226 00889024013162

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown