BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIATRICS 3.5MM, 80 DEGREE, 4-HOLE, 5 DEGREE FLARE, PLATE

    MDR report key: 7651935 · Received June 29, 2018

    Report

    Report Number
    3006460162-2018-00043
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    May 18, 2018
    Report Date
    June 28, 2018
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    HRS
    UDI-DI
    0084113213015
    PMA / PMN Number
    K083286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM: 00-0903-2648, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 48MM, LOT: 160996-J; ITEM: 00-0903-2650, 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM, LOT: 162818-J - QUANTITY: 2; ITEM: 00-0903-2530, 3.5MM SELF TAPPING CORTICAL SCREW, T15 HEX, SIZE 30MM, LOT: 163725-J; ITEM: 00-0903-2534, 3.5MM SELF TAPPING CORTICAL SCREW, T15 HEX, SIZE 34MM, LOT: 164341-J; ITEM: 00-0903-2532, 3.5MM SELF TAPPING CORTICAL SCREW, T15 HEX, SIZE 32MM, LOT: 152163-J. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006460162-2018-00044, 3006460162-2018-00045, AND 3006460162-2018-00046.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A SURGICAL PROCEDURE TO CORRECT A VALGUS DEFORMITY OF THE DISTAL FEMUR, THE IMPLANTED PLATE WAS FOUND TO HAVE SUBSIDED INTO FLEXION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE IT WAS DISCOVERED THAT THREE DISTAL LOCKING SCREWS HAD BENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495425 ORTHOPEDIATRICS 3.5MM, 80 DEGREE, 4-HOLE, 5 DEGREE FLARE, PLATE DISTAL FEMORAL OSTEOTOMY PLATE HRS ORTHOPEDIATRICS, INC N/A 171000-C 0084113213015

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention