BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ORTHOPEDIATRICS PEDINAIL RECON SCREW

    MDR report key: 7153462 · Received December 28, 2017

    Report

    Report Number
    3006460162-2017-00032
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    November 21, 2017
    Report Date
    December 28, 2017
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HWC
    PMA / PMN Number
    K083726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: UNKNOWN ORTHOPEDIATRICS PEDINAIL IM FEMORAL NAIL, ITEM #: UNKNOWN, LOT #: UNKNOWN. (B)(6). THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460162-2017-00031.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN INTRAMEDULLARY NAIL, FOLLOW-UP X-RAYS DISCOVERED THAT THE IM NAIL AND SCREW FRACTURED AT THE PROXIMAL SCREW HOLE. THE DIAGNOSIS WAS MADE THREE YEARS POST OPERATIVELY. THE PATIENT HAS BEEN SCHEDULED FOR A REVISION PROCEDURE AT AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932231 UNKNOWN ORTHOPEDIATRICS PEDINAIL RECON SCREW PEDINAIL RECON SCREW HWC ORTHOPEDIATRICS, CORP N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention