BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMED 2.3MM X 24MM LOCKING CORTICAL SCREW

    MDR report key: 1994438 · Received February 17, 2011

    Report

    Report Number
    3025141-2011-00005
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: SURGICAL TECHNIQUE INDICATES A MINIMUM OF 6 DISTAL SCREWS SHOULD BE USED IN THE FOUR MOST DISTAL HOLES AND TWO RADIAL STYLOID HOLES. THE PLATE WAS RETURNED WITH ONLY 4 SCREW HEADS IN THE PLATE WHICH INDICATES THE OTHER HOLES WERE NOT FILLED. IT IS POSSIBLE THE HOLES WERE FILLED AND THE SCREWS WERE THEN REMOVED AFTER EXPLANTATION, BUT ANY SCREWS IN THOSE LOCATIONS WOULD MOST LIKELY HAVE BROKEN AT THE SAME TIME THE OTHER FOUR SCREWS BROKE. WHILE IT CAN BE ASSUMED THAT ONLY 4 SCREWS WERE USED, IT IS UNCLEAR HAD ALL 6 SCREWS BEEN USED THAT IT WOULD HAVE PREVENTED THIS EVENT FROM OCCURING. IN THE INITIAL REPORT FROM THE SURGEON, THE PATIENT LIFTED SOMETHING UP BUT THERE IS NO INFORMATION AS TO HOW HEAVY THE OBJECT WAS OR HOW LONG AFTER THE SURGERY THIS ACTIVITY WAS PERFORMED. CONCLUSION: A DEFINITIVE CONCLUSION CANNOT BE DETERMINED WITHOUT ADDITIONAL INFORMATION AS DESCRIBED IN THE EVALUATION SECTION ABOVE. IT IS UNCLEAR IF THE INCIDENT WOULD STILL HAVE OCCURRED IF 6 DISTAL SCREWS WERE USED INSTEAD OF FOUR AND THE FORCES EXERTED ON THE SCREWS ARE NOT KNOWN AT THIS TIME. THEREFORE, THE CAUSE OF THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    A 2.3MM X 24MM LOCKING CORTICAL SCREW WAS IMPLANTED WITH AN ACU-LOC VDR PLATE, NARROW, LEFT ON (B)(6) 2010, AND A REVISION SURGERY DONE ON (B)(6) 2011. PER THE SURGEON, THE PATIENT REPORTED THAT HE WAS LIFTING SOMETHING AND FELT A POP. IT WAS DETERMINED THAT THE FOUR DISTAL SCREWS BROKE APPROXIMATELY 5-6 THREADS DOWN FROM THE HEAD (ON EACH). THE SCREWS BROKE IN SUCH A MANNER AS TO LEAVE A PORTION IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUMED 2.3MM X 24MM LOCKING CORTICAL SCREW BONE SCREW HRS ACUMED LLC CO-T2324 214285

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention