BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM 90 DEG DFOS PLATE, 4MM OFFSET, 4-HOLE

    MDR report key: 9717158 · Received February 17, 2020

    Report

    Report Number
    3006460162-2020-00029
    Event Type
    Injury
    Date Received
    February 17, 2020
    Date of Event
    August 14, 2019
    Report Date
    February 13, 2020
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HRS
    PMA / PMN Number
    K083286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE: (B)(4). COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION, HOSPITAL SCRAPPED IT. REPORTED EVENT WAS NOT CONFIRMED AFTER EVALUATING THE CUSTOMER SUBMITTED RADIOGRAPH. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE INVOLVED DEVICE IS UNKNOWN. THERE WERE NO RECENT DESIGN CHANGES PRIOR TO MANUFACTURING. RISK MANAGEMENT FILE REVIEW WAS DEEMED APPROPRIATE. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED, THE PLATE DID NOT APPEAR TO BE BENT OR FRACTURED IN THE CUSTOMER SUBMITTED RADIOGRAPH. CONCOMITANT DEVICES: 3.5MM LOCKING CORTICAL SCREW W/ T15 HEX, SIZE 22MM: ITEM NUMBER; 00-0903-2622, LOT NUMBER; UNKNOWN. 3.5MM LOCKING CORTICAL SCREW W/ T15 HEX, SIZE 24MM: ITEM NUMBER; 00-0903-2624, LOT NUMBER; UNKNOWN. 3.5MM LOCKING CORTICAL SCREW W/ T15 HEX, SIZE 50MM: ITEM NUMBER; 00-0903-2650, LOT NUMBER; UNKNOWN. 3.5MM SELF TAPPING CORTICAL SCREW W/ T15 HEX, SIZE 22MM: ITEM NUMBER; 00-0903-2522, LOT NUMBER; UNKNOWN. 3.5MM SELF TAPPING CORTICAL SCREW W/ T15 HEX, SIZE 44MM: ITEM NUMBER; 00-0903-2644, LOT NUMBER; UNKNOWN. 3.5MM SELF TAPPING CORTICAL SCREW W/ T15 HEX, SIZE 40MM: ITEM NUMBER; 00-0903-2640, LOT NUMBER; UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL FEMORAL OSTEOTOMY SYSTEM PLATE ROTATED IN THE DISTAL PORTION OF THE BONE. A REVISION SURGERY TOOK PLACE APPROXIMATELY SIX WEEKS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181370 3.5MM 90 DEG DFOS PLATE, 4MM OFFSET, 4-HOLE DISTAL FEMORAL OSTEOTOMY SYSTEM HRS ORTHOPEDIATRICS, CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention