BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

    MDR report key: 4247747 · Received November 13, 2014

    Report

    Report Number
    2520274-2014-14692
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 20, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JDO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PLATE/UNKNOWN LOT. PART NUMBERS 481.140S 135 DEG TI LC-DHS® PLATE-STANDARD BARREL 4 HOLES/78MM AND 481.871S LOCKING TROCHANTER STABILIZING PLATE FOR DHS, ADJUSTABLE, WERE REPORTED, BUT IT IS UNKNOWN WHICH ONE WAS INVOLVED IN THE COMPLAINT. PART 481.140S: K953607; PART 481.871S: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PRODUCTS WERE USED FOR FEMUR TROCHANTER COMMINUTED FRACTURE ON (B)(6) 2014. THE PATIENT HAD A PAIN THE NEXT DAY. ACCORDING TO X-RAY, THE PATIENT¿S BONE CRACKED AT THE DISTAL PART. THE PATIENT CONTINUED TO EXPERIENCE PAIN. ON (B)(6) 2014, IT WAS FOUND OUT BY X-RAY THAT THE FIXATION AT THE DISTAL PART WAS BROKEN. THE PATIENT WALKED UNDER WEIGHT-BEARING CONTROL AFTER THE SURGERY. THIS REPORT IS FOR AN UNKNOWN PLATE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734205 APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR JDO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention