BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.7MM MTX FULL, 10

    MDR report key: 17859792 · Received October 3, 2023

    Report

    Report Number
    0002023141-2023-02732
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    March 23, 2023
    Report Date
    February 1, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019034
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K113753/K112160.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) TMTWB10, (IMP TM 4.7MM MTX FULL, 10) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE. NO DAMAGE IDENTIFIED OR SIGNS OF MALFUNCTION THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. MEASUREMENTS MATCH DRAWING. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1231424. 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 1231424 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: LOSS OF INTEGRATION : PERFORATED SINUS. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE MISSING OR CONFUSING INSTRUCTIONS FOR USE, CLINICIAN INADVERTENTLY SELECTS AN LENGTH OF IMPLANT THAT IS TOO LONG FOR THE DEPTH OF OSTEOTOMY PREPARED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT WAS NON-VERIFIABLE 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT LOST INTEGRATION DUE TO SINUS PERFORATION AND WAS REMOVED PER INDICATED: LOSS OF INTEGRATION, SINUS PERFORATION. ADDITIONAL APPOINTMENT REQUIRED TO PLACE A NEW IMPLANT. NONE SYMPTOMS WERE REPORTED AS A RESULT OF THE EVENT.

    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
    416963 IMP TM 4.7MM MTX FULL, 10 DENTAL IMPLANT DZE ZIMMER DENTAL 1231424 00889024019034

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female