BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIATRICS 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 60MM

    MDR report key: 7216453 · Received January 24, 2018

    Report

    Report Number
    3006460162-2018-00007
    Event Type
    Injury
    Date Received
    January 24, 2018
    Date of Event
    October 26, 2017
    Report Date
    January 24, 2018
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HWC
    PMA / PMN Number
    K140431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT PRODUCT: CATALOG NUMBER: 00-1030-000, 4.0 MM BONE SCREW WASHER, LOT NUMBER: 91603243-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 DURING A CORRECTION PROCEDURE OF A MEDIAL EPICONDYLE FRACTURE, THE 4.0 CANNULATED SCREW FRACTURED THROUGH THE THREADS. THE SURGEON TESTED THE FIXATION OF THE SCREW AND DECIDED TO LEAVE IT IN THE BONE. THE ARM WAS SPLINTED FOR 3 WEEKS. UPON REMOVAL OF THE SPLINT, THE PATIENT COMPLAINED OF A PROMINENCE IN HIS ELBOW AND X-RAYS REVEALED THAT THE REMAINING PART OF THE SCREW HAD BACKED OUT. THE PATIENT WAS REVISED TO REMOVE THE SCREW FRAGMENTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58929 ORTHOPEDIATRICS 4.0MM CANNULATED CANCELLOUS SCREW, FULL THREAD, T15, 60MM PEDILOC FRAGMENT SCREW HWC ORTHOPEDIATRICS, CORP N/A I08B2-A

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R