BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEXALOBE, 26MM

    MDR report key: 7631549 · Received June 22, 2018

    Report

    Report Number
    3006460162-2018-00041
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    May 24, 2018
    Report Date
    November 23, 2019
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HWC
    UDI-DI
    0084113211089
    PMA / PMN Number
    K100240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE MANUFACTURE DATE: 20-JUN-2017. (B)(4). PRODUCT WAS EVALUATED AND COMPLAINT OF DEVICE FRACTURE WAS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM: 00-0903-2628, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 26MM, LOT: 170078-J; ITEM: 00-0903-2622, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 22MM, LOT: 162305-J; ITEM: 00-0903-2512, 3.5MM SELFT TAPPING CORTICAL SCREW, T15 HEX, 12MM, LOT: 161244-J; ITEM: 00-0903-2518, 3.5MM SELF TAPPING CORTICAL SCREW, T15 HEX, 18MM. LOT: 174258-J; ITEM: 00-0903-2516, 3.5MM SELF TAPPING CORTICAL SCREW, T15 HEX, 16MM. LOT: 161459-J; ITEM: 00-0907-2103, 130 DEGREE, 3.5MM LOCKING PROXIMAL FEMORAL PLATE, 3-HOLE, LOT: 041626-G. PRODUCT HAS BEEN RECEIVED BY ORTHOPEDIATRICS AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A SURGICAL PROCEDURE TO CORRECT A PROXIMAL FEMORAL FOCAL DEFICIENCY, THE SCREWS WERE DISCOVERED TO HAVE DISSOCIATED FROM THE BONE AND FRACTURED. IT WAS ALSO REPORTED THAT THE PATIENT WAS DIAGNOSED WITH POOR BONE QUALITY AND WAS NOT CASTED FOLLOWING THE PROCEDURE. THE PATIENT UNDERWENT A REVISION PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470479 ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEXALOBE, 26MM LOCKING CORTICAL SCREW HWC ORTHOPEDIATRICS, CORP N/A 173894-J 0084113211089

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention