BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 5462375 · Received February 26, 2016

    Report

    Report Number
    2520274-2016-11328
    Event Type
    Injury
    Date Received
    February 26, 2016
    Report Date
    February 5, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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

    DEVICE PRO CODE WAS SUPPOSED TO BE HSB NOT HWB. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN BLADE/UNKNOWN LOT NUMBER. UNKNOWN IF DEVICE IS/NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 DEVELOPED AN INFECTION AND UNDERWENT REMOVAL OF HARDWARE. A PATIENT, WHO WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL (TFN), PRESENTED WITH REDNESS AND SWELLING ALONG THE RIGHT HIP. HE WAS DIAGNOSED WITH INFECTION AND UNDERWENT REMOVAL OF TFN, A LAG SCREW AND TWO DUAL FORCE SCREWS ON (B)(6) 2016. A CULTURE WAS TAKEN; RESULTS ARE PENDING AND WILL NOT BE AVAILABLE. IT WAS NOTED THAT THIS WAS THE PATIENT'S THIRD PROCEDURE. THERE WAS NO SURGICAL DELAY. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THERE ARE NO PLANS AT THIS TIME TO IMPLANT OTHER DEVICES. NO ADDITIONAL INFORMATION AVAILABLE. THIS REPORT IS 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120960 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention