BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIATRICS OP SPINE SYSTEM

    MDR report key: 3010261 · Received March 14, 2013

    Report

    Report Number
    3006460162-2013-00007
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ORTHOPEDIATRICS CORP
    Product Code
    HRS
    PMA / PMN Number
    K120291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A SIX MONTH FOLLOW-UP, THE X-RAYS SHOWED THAT ONE OF THE SETS SCREWS HAD COME OUT OF THE TULIP HEAD. A REVISION SURGERY TOOK PLACE ON (B)(6) 2013. THE SURGEON IDENTIFIED THE FAILURE OF THE SCREW TO HOLD AND A SMALL LOSS OF CORRECTION AT THE LOWEST LEVEL INSTRUMENTED. THE CHILD WAS COMPLETELY ASYMPTOMATIC. IN THE REVISION SURGERY, THE SURGEON FOUND THAT THE BULK OF THE FUSION WAS INTACT EXCEPT AT THE LOWER SEGMENT WHERE THERE WAS PARTIAL BONE HEALING. HE WAS ABLE TO RE-REDUCE THE LOWER END OF THE ROD AND FIX IT WITH A NEW SET SCREW. HE REPLACED TWO OTHER SET SCREWS TO BE SURE THE FIXATION WAS SECURE AND ADDED ADDITIONAL BONE GRAFT AT THE LOWER LEVEL. HE WAS ABLE TO RECOVER SOME OF THE LOST CORRECTION. THE CHILD WAS BRACED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108441 ORTHOPEDIATRICS OP SPINE SYSTEM PEDICLE SCREW SPINAL SYSTEM HRS ORTHOPEDIATRICS CORP NA M-33425

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other| R