BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02791

    MDR report key: 3130665 · Received May 24, 2013

    Report

    Report Number
    2520274-2013-02791
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS IMPLANTED ON AN UNKNOWN DATE IN 2009. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. UPDATE EVENT DESCRIPTION TO CAPTURE 2 BROKEN RODS AND 4 UNKNOWN CAPS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE IN 2003, THE PATIENT HAD DECOMPRESSION SURGERY WITH NO FUSION. ON AN UNKNOWN DATE IN 2009, A SECOND PROCEDURE OCCURRED WITH FUSION. PATIENT PRESENTED TO SURGEON ON UNKNOWN DATE WITH BACK PAIN. X-RAYS AND EXAMINATION REVEALED A BROKEN ROD ON THE RIGHT SIDE AT APPROXIMATELY L3-L4. THE FUSION WAS REVISED ON (B)(6) 2013 WITH NOTED PSEUDOARTHROSIS AT L3-L4. THIS REPORT IS FOR AN UNKNOWN CAP. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    X-RAYS AND EXAMINATION REVEALED 2 BROKEN RODS ON THE RIGHT SIDE AT APPROXIMATELY L3-L4. THIS REPORT IS FOR 4 UNKNOWN CAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232483 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention