BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXLOCK EXTREME

    MDR report key: 2427505 · Received January 5, 2012

    Report

    Report Number
    3005039508-2011-00018
    Event Type
    Injury
    Date Received
    January 5, 2012
    Date of Event
    October 21, 2011
    Report Date
    January 11, 2012
    Manufacturer
    ORTHOHELIX SURGICAL DESIGN
    Product Code
    HRS
    PMA / PMN Number
    K073624
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE RETURNED PRODUCT HAS SIGNS OF WEAR, LIKELY FROM THE IMPLANTATION, BUT IS UNDAMAGED AND NOT LIKELY THE CAUSE OF THE ADVERSE EVENT. ADDITIONAL INFORMATION: NONE OF THE IMPLANTS LISTED BELOW WERE BROKEN OR DAMAGED. MODEL # MTP-002-SRN, LOT# 1641041, DEVICE MANUFACTURE DATE: 01/2011. MODEL # MFT-011-35-20, LOT# UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. MODEL # MFT-011-35-16, LOT# 1504041, DEVICE MANUFACTURE DATE: 12/2010. MODEL # MFT-021-35-16, LOT# 1640051, DEVICE MANUFACTURE DATE: 05/2011. MODEL # MFT-021-35-12, LOT# 1640031, DEVICE MANUFACTURE DATE: 03/2011. MODEL # MFT-011-40-10, LOT# 1504081, DEVICE MANUFACTURE DATE: 12/2010.

    Description of Event or Problem · 1

    PATIENT HAS A HISTORY OF DEGENERATIVE JOINT DISEASE AND PAINFUL BUNION AND SICKLE CELL TRAIT. A FEW MONTHS AGO, PATIENT HAD A SILVER BUNIONECTOMY WITH FIRST METATARSOPHALANGEAL JOINT FUSION. POSTOPERATIVELY, THE PATIENT DEVELOPED EMBOLUS TO THE HALLUX AND THE HALLUX DEVELOPED GANGRENOUS CHANGES. THE PATIENT RETURNED FOR SURGERY FOR AMPUTATION OF THE HALLUX AND REMOVAL OF THE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXLOCK EXTREME BONE FIXATION PLATES AND SCREWS HRS ORTHOHELIX SURGICAL DESIGN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R