BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.3MM X 35MM CANCELLOUS LOCKING SCREW

    MDR report key: 2241496 · Received September 9, 2011

    Report

    Report Number
    3025141-2011-00033
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ACUMED LLC
    Product Code
    HSB
    PMA / PMN Number
    K920666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDICAL DEVICE REPORTS SUBMITTED RELATED TO THIS EVENT ARE: 3025141-2011-00034 AND 3025141-2011-00035.

    Description of Event or Problem · 1

    THE DOCTOR IMPLANTED ACUMED PRODUCT: 11MM X 150MM POLARUS LOCKING HUMERAL ROD, TWO 5.3MM X 35MM CANCELLOUS LOCKING SCREWS PROXIMALLY AND TWO 3.5MM X 25.0MM CORTICAL SCREWS DISTALLY. THE PATIENT CAME BACK A COUPLE MONTHS LATER COMPLAINING OF PAIN, AND THE X-RAYS SHOWN THAT BOTH THE PROXIMAL 5.3 LOCKING SCREWS HAD BACKED OUT OF THE ROD. THE DOCTOR "BELIEVED" THE PATIENT WAS NOT VERY COMPLIANT. HOWEVER, THE DOCTOR STATED THAT THE ROD IS SUPPOSED TO BE LOCKING AND THE PROXIMAL SCREWS STILL BACKED OUT. THE PRODUCT HAS NOT BEEN REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.3MM X 35MM CANCELLOUS LOCKING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ACUMED LLC HCA-L5335-S 246003

    Patients

    Seq Age Sex Outcome Treatment
    1