BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S HOOK

    MDR report key: 5067745 · Received September 4, 2015

    Report

    Report Number
    MW5056071
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 7, 2015
    Report Date
    September 4, 2015
    Manufacturer
    SYNTHES, INC
    Product Code
    MDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD AN IMPLANTATION OF VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIBS, RIBS TO PELVIS DEVISE WHICH WAS CHANGED TO A RIB TO LAMINA DEVICE 2 YEARS AGO, AND BACK TO A RIB TO PELVIS DEVICE. UPON X-RAYS FOR PREOP OF HER SURGERY IT WAS NOTED THAT THE PELVIC HOOK HAD BROKEN. PATIENT UNDERWENT A RIGHT PELVIC HOOK REPLACEMENT AND REVISION WITH RIGHT TITANIUM RIB DEVICE EXPANSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588536 S HOOK MDI SYNTHES, INC 04.601.00

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other