BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIFRAG 4.0MM CANNULATED CANCELLOUS SCREW, T15 HEX, FULL THREAD, 20MM

    MDR report key: 9715198 · Received February 16, 2020

    Report

    Report Number
    3006460162-2019-00055
    Event Type
    Malfunction
    Date Received
    February 16, 2020
    Date of Event
    September 7, 2019
    Report Date
    September 12, 2019
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    HWC
    PMA / PMN Number
    K140431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT DEVICES: ITEM NUMBER: 00-0903-2526 3.5MM SCREW, LOT NUMBER:178044-J; ITEM NUMBER: 00-0903-2526 3.5MM SCREW, LOT NUMBER: 178044-J; ITEM NUMBER: 00-0903-2520 3.5MM SCREW, LOT NUMBER: 183989-J. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460162-2019-00056, 3006460162-2019-00057, AND 3006460162-2019-00058.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING THE PLACEMENT OF A PLATE CONSTRUCT TO CORRECT A HUMERUS FRACTURE, A SCREW FRACTURED DURING REMOVAL. THE SURGEON WAS ATTEMPTING TO REMOVE THE SCREW AS IT WAS DETERMINED TO BE TOO LONG. THE CONSTRUCT WAS REMOVED IN ATTEMPT TO REMOVE THE FRACTURED SCREW. THREE ADDITIONAL SCREWS FRACTURED DURING THE REMOVAL. A DELAY OF ONE HOUR WAS NOTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178406 PEDIFRAG 4.0MM CANNULATED CANCELLOUS SCREW, T15 HEX, FULL THREAD, 20MM SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1