BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING CANNULATED BLADE PLATE SCREW

    MDR report key: 3904726 · Received May 27, 2014

    Report

    Report Number
    3006460162-2014-00006
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    February 19, 2014
    Manufacturer
    ORTHOPEDIATRICS CORP
    Product Code
    HWC
    PMA / PMN Number
    K110959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL RISK ASSESSMENT (HHE) DETERMINED THAT THIS MALFUNCTION DID NOT MEET THE REQUIREMENTS OF A MANDATORY REPORTABLE ADVERSE EVENT PER 21 CFR803.50, BUT THE FIRM WISHES TO REPORT THE MALFUNCTION.

    Description of Event or Problem · 1

    OSTEOTOMY MALUNION. X-RAY INDICATES A BROKEN LOCKING SCREW. SURGEON FEELINGS ABOUT FACTORS CONTRIBUTING TO THE NON-UNION INCLUDE INADEQUATE COMPRESSION AT THE IT OSTEOTOMY SITE AND, PERHAPS, INSUFFICIENT BONE GRAFT. AT NO TIME HAS PT HAD ANY PAIN. HE IS CURRENTLY WALKING WITH NO ASSISTIVE DEVICES AND CONTINUES TO HAVE NO SYMPTOMS. THE SURGEON HAS DECIDED TO UTILIZE A BONE GROWTH STIMULATOR AND RE-ASSESS IN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311946 LOCKING CANNULATED BLADE PLATE SCREW BONE SCREW HWC ORTHOPEDIATRICS CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR