BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 4173385 · Received October 15, 2014

    Report

    Report Number
    2520274-2014-14141
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 17, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN TROCHANTERIC FIXATION NAIL. ADDITIONAL PRODUCT CODE: HWC. (B)(4). 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

    IT WAS REPORTED THAT AFTER UNDERGOING AN URGENT SURGERY INVOLVING A TROCHANTERIC FIXATION NAIL (TFN), A PATIENT WHO HAD TESTED POSITIVE FOR A TITANIUM ALLERGY PRIOR TO SURGERY, BEGAN TO EXPERIENCE ALLERGIC SYMPTOMS; PAIN, SORES EVERYWHERE AND RESPIRATORY PROBLEMS. THE PATIENT HAS RECEIVED TREATMENTS, BUT REPORTS AN EXPLANT MUST BE SCHEDULED WITHIN A YEAR AS HER CONDITION IS LIFE THREATENING. THIS REPORT IS FOR AN UNKNOWN TROCHANTERIC FIXATION NAIL. THIS IS REPORT NUMBER 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654189 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention