BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01599

    MDR report key: 3012042 · Received March 20, 2013

    Report

    Report Number
    2520274-2013-01599
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 18, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    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.

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL EVALUATION WAS PERFORMED AND THE REPORT STATED THE FOLLOWING: THE REVIEW OF THE RAW MATERIAL CERTIFICATE AND MANUFACTURING DOCUMENTS SHOWED NO DEVIATION ACCORDING TO OUR SPECIFICATIONS. THE COMPLAINED ARTICLES WERE SENT TO OUR PRODUCT DEVELOPMENT CENTER FOR FURTHER INVESTIGATION. THE INVESTIGATION SHOWS NORMAL TRACES OF USAGE, BESIDES NO INCONSPICUOUS. THE EXACT CAUSE OF DAMAGE CANNOT BE ELICITED. WE ASSUME THAT WHILE THE FINAL TIGHTENING THE LOCKING CAP WAS NOT RIGHT-ANGLED TO THE ROD, WHICH WAS LEADING TO THE LOOSENING OF THE LOCKING CAP. THE DESIRED ORIENTATION OF THE SCREW HEAD IS POSSIBLE WITH VERTICAL ALIGNMENT OF THE ABUTMENT OPPOSITE THE ROD.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WITH PREVIOUS HISTORY OF SPONDYLOLISTHESIS AND SPINAL FUSION AT L4-5 AND NOTED PSEUDO ARTHROSIS WAS RETURNED TO THE OR ON (B)(6) 2013 FOR SURGICAL INTERVENTION DUE TO A LOOSE LOCKING CAP AT THE LEFT L4 VERTEBRAL BODY. THE LOCKING CAP HAD MIGRATED INTO THE PATIENTS MUSCULATURE. THE DETAILS OF THE REVISION PROCEDURE ARE UNKNOWN AT THE PRESENT TIME. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116080 NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention