BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP, TSV, 4.7, 8, MTXF, MG, HA

    MDR report key: 17084959 · Received June 8, 2023

    Report

    Report Number
    0002023141-2023-01613
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    April 24, 2023
    Report Date
    September 19, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PMA/510(K) NUMBER : K133339.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D4: ADDITIONAL DEVICE INFORMATION. D9: DEVICE AVAILABILITY. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT . H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H4: DEVICE MANUFACTURER DATE. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. ZIMVIE RECEIVED ONE (1) TSVTWH8, (IMP, TSV, 4.7, 8, MTXF, MG, HA) FOR EVALUATION. A VISUAL EVALUATION WAS PERFORMED, THERE WAS SIGNS OF USAGE. THERE WAS SOME BONE/BLOOD DEBRIS ON THE INTERNAL THREADS. THE COVER SCREW DIDN¿T ENGAGE WITH THE IMPLANT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1256039. 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 1256039 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : FUNCTIONAL : DEVICE MALFUNCTION¿ BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS MISSING OR CONFUSING INSTRUCTIONS FOR USE OR THE CLINICIAN DAMAGES IMPLANT RESTORATIVE SEATING SURFACE (E.G. SCRATCHES, DENTS RESULTING IN REMOVAL OF IMPLANT MATERIAL). THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE COVER SCREW DIDN'T ENGAGE WITH THE IMPLANT. THE REPORTED EVENT WAS

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT COVER SCREW DOES NOT SCREW AT TOOTH SITE 15. A NEW IMPLANT WAS PLACED TO FINISH THE PROCEDURE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057524 IMP, TSV, 4.7, 8, MTXF, MG, HA DENTAL IMPLANT DZE ZIMMER DENTAL 1256039

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose