BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOFIX

    MDR report key: 6541549 · Received May 3, 2017

    Report

    Report Number
    3009158523-2017-00001
    Event Type
    Injury
    Date Received
    May 3, 2017
    Date of Event
    March 18, 2015
    Report Date
    April 13, 2017
    Manufacturer
    NEOORTHO
    Product Code
    HWC
    UDI-DI
    07898624863216
    PMA / PMN Number
    K13733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) UNIT - 901 185 - 800 010 691 LOT. TWO (2) UNITS - 901 183 - LOT 3608694. ONE (1) UNIT - 901 183 - LOT 3618229. THE SCREWS AND PLATE WERE PRODUCED IN ACCORDANCE WITH THE SPECIFIED / PROJECTED. THERE IS NO EVIDENCE THAT THE FAILURE HAS OCCURRED BY MATERIAL FAIL. CONCLUSION: THE MATERIAL FAILURE OCCURRED BY THE USE OF ONLY FOUR (4) SCREWS IN THE DISTAL PART OF THE PLATE (900.502). AND ALSO BECAUSE OF THE DISTAL FEMUR OF THE PATIENT COMPROMISED BY THE PRESENCE OF THE KNEE PROSTHESIS AND INTRAMEDULLARY BONE CEMENT AND RELEASING THE LOAD BEFORE SIGNS OF CONSOLIDATION DISPLAY REGION.

    Description of Event or Problem · 1

    IN A SURGERY PERFORMED, A 5-HOLE LEFT LESS INVASIVE DISTAL FEMUR PLATE WAS IMPLANTED, APPROXIMATELY TWO MONTHS AFTER THE PROCEDURE THE PATIENT RETURNS FOR ANOTHER SURGERY BECAUSE THE DISTAL FEMUR PLATE WAS LOOSE AND HAD BROKEN FIXING SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322794 NEOFIX SH SELF DRILLING LOCKING SCREW HWC NEOORTHO N/A 80010691 07898624863216

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention