BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERCLAGE FIXATION

    MDR report key: 4100896 · Received September 19, 2014

    Report

    Report Number
    2520274-2014-13736
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 21, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN CERCLAGE WIRE/UNKNOWN LOT. DEVICE HAS NOT BEEN EXPLANTED. 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

    IT WAS REPORTED THAT A PATIENT HAD A HELICAL BLADE PLACED IN TREATMENT OF A HIP AND SHATTERED FEMUR. SINCE TREATMENT FROM ORTHOPEDIST AND RHEUMATOLOGIST, PATIENT EXPERIENCES SIGNS AND SYMPTOMS OF CONSTANT ACHE AND PAIN. IT WAS ALSO REPORTED THAT THE PATIENT IS CONCERNED THAT HE MAY POSSIBLY BE HAVING A TITANIUM REACTION. DOCTOR'S RECOMMENDATION IS A FULL HIP REPLACEMENT IF CONSTANT ACHE CONTINUES. TO DATE NO EXPLANT IS SCHEDULED. THIS REPORT IS FOR AN UNKNOWN CERCLAGE WIRE. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583554 CERCLAGE FIXATION JDQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention