BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILLABLE BONE VOID FILLER

    MDR report key: 17700110 · Received September 7, 2023

    Report

    Report Number
    2530154-2023-00001
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    August 3, 2023
    Report Date
    October 2, 2023
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    MQV
    PMA / PMN Number
    K173362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER WAS CONTACTED THREE TIMES. NO PATIENT INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED STATED THAT DEVICE WAS IMPLANTED AT TIBIAL PLATEAU. THE PATIENT RETURNED THE FOLLOWING WEEK AND ANOTHER BONE VOID FILLER WAS USED TO RAISE THE TIBIAL PLATEAU. REVIEW OF THE MANUFACTURING RECORDS REVEALED THAT THE DEVICE MET ALL SPECIFICATIONS. THE INFORMATION PROVIDED BY THE REPORTER STATES THAT THE USER UTILIZED MORE SALINE TO MIX THE POWDER THEN INSTRUCTED IN THE DEVICE'S INSTRUCTIONS FOR USE WHICH LIKELY CONTRIBUTED TO THE PRODUCT CONSISTENCY ISSUES.

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED FOR EVALUATION. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ONGOING AND LIMITED TO REVIEW PROVIDED BY USER AND DEVICE HISTORY RECORD REVIEW. RESULTS AND CONCLUSIONS WILL BE SUBMITTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BONE VOID FILLER HAD A CHUNKY POWDERY APPEARANCE AFTER INITIAL MIXING. AFTER ADDING ADDITIONAL SALINE AND MIXING FOR ADDITIONAL TIME, THE BONE VOID FILLER HAD MORE OF A TOOTH-PASTE CONSISTENCY. THE BONE VOID FILLER WAS ABLE TO BE APPLIED INTO THE VOID. AFTER WAITING FOR 5 MINUTES, THE SURGEON CONTINUED THE CASE AND ATTACHED A 3.5 VA PROXIMAL TIBIA PLATE. AFTER 10 MINUTES THE SURGEON TOOK THE FINAL X-RAYS AND NOTED THAT THE LATERAL SIDE OF THE DEFECT HAD COLLAPSED. IT IS UNKNOWN AT THIS TIME WHAT, IF ANY, REMEDIAL ACTIONS WERE TAKEN. IT WAS REPORTED THAT THE CONSISTENCY OF THE EXPOSED BVF WAS CHALKY AND WAS FLAKING OFF AS THE SURGEON TOUCHED IT. THERE WAS A 15 MIN SURGICAL DELAY BUT THERE WERE NO PATIENT CONSEQUENCES AT THE COMPLETION OF THE PROCEDURE. THE PATIENT RETURNED THE FOLLOWING WEEK AND HAD THE SURGERY REVISED AS THE VOID HAD COLLAPSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2121930 DRILLABLE BONE VOID FILLER RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE MQV DSM BIOMEDICAL 21005-05 7011816

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 3.5 VA PROXIMAL TIBIA PLATE