BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01271

    MDR report key: 2991002 · Received March 6, 2013

    Report

    Report Number
    2520274-2013-01271
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 5, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(46 AS FOLLOWS: PATIENT WAS IN A DISCECTOMY PROCEDURE ON AN UNKNOWN DATE. PATIENTS DISC WAS REPLACED WITH A CAGE. SURGEON ALSO DECIDED TO PERFORM A SPINAL FUSION. SURGEON DECIDED TO USE A CSLP VARIABLE ANGLE SYNTHES LEVEL TWO AND OUT FIVE 21MM BICORTICAL SCREWS, AND ONE 20MM BICORTICAL SCREW. ONE DAY POST-OPERATIVE, SURGEON PERFORMED A REVISION SURGERY, FOR AN UNKNOWN REASON, DURING WHICH ALL SIX SCREWS WERE REPLACED WITH 16MM MONOCORTICAL SCREWS. IT IS NOTED THAT PATIENT HAD GOOD BONE QUALITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR THE 20MM BICORTICAL SCREW. THIS IS 1 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95354 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention