BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM DFOS PLATE 90 DEGREE, 18FLARE 4MM OFFSET, 4 HOLE

    MDR report key: 14207092 · Received April 25, 2022

    Report

    Report Number
    MW5109356
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 10, 2022
    Report Date
    April 20, 2022
    Manufacturer
    ORTHOPEDIATRICS, CORP.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "REMOVAL OF ORTHOPEDIC PLATING SYSTEM 'BIL' FOR EXTENSION OSTEOTOMY DUE TO DEBRIDEMENT OF TISSUE BELOW DEEP FASCIA LEFT DISTAL FEMORAL REGION. LESS THAN 20 CM2 FOR METALLIC DEBRIS FROM SCREW HEAD CORROSION; SAME TO RIGHT SIDE WITH SAME AMOUNT OF DEBRIS. REASON FOR SURGERY - PAINFUL ORTHOPEDIC HARDWARE LEFT AND RIGHT DISTAL FEMUR "POSTOP DIAGNOSES - ACQUIRED COMPLICATION ORTHOPEDIC INTERNAL FIXATION LEFT AND RIGHT DISTAL FEMUR."

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER FOR MW5109356 ON 05/10/2022: PLEASE NOTE THE SCREWS DO NOT HAVE A LOT. I HAVE INCLUDED THE LOT FOR THE PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119374 4.5MM DFOS PLATE 90 DEGREE, 18FLARE 4MM OFFSET, 4 HOLE PLATE, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP. 00-1050-6104 187280-B
    119375 4.5MM DFOS PLATE 90 DEGREE, 18FLARE 4MM OFFSET, 4 HOLE PLATE, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP. 00-1050-6104 187280-B
    119376 SCREW CANN 4.5X50MM T20 HEX - LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP.
    119377 SCREW CORT 4.5X24MM NL F/T W/T20 HEXALOBE - LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP.
    119378 SCREW CORT 4.5X32MM NL F/T W/T20 HEXALOBE - LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP.
    119379 SCREW CANN 4.5X55MM T20 HEX - LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP. 00-0907-4755
    119380 SCREW CANN 4.5X50MM T20 HEX - LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP.
    119381 SCREW CORT 4.5X24MM NL F/T W/T20 HEXALOBE - LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP.
    119382 SCREW CANN 4.5X55MM T20 HEX - LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP. 00-0907-4755
    119383 SCREW CORT 4.5X26M T20HEX F/T - LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP.
    119384 THRD CORT FULL 4.5X32MM LOCKING WITH T20 HEXALOBE - LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP.
    119385 SCREW CANN 4.5X45MM T20 HEX - LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP. 00-0907-4745
    119386 SCREW CORT 4.5X24M T20HEX F/T - LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP.
    119387 SCREW CORT 4.5X28MM NL F/T W/T20 HEXALOBE- LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP.
    119388 SCREW CORT 4.5X30M T20HEX F/T - LOG50463 SCREW, FIXATION, BONE HWC ORTHOPEDIATRICS, CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female Required Intervention