BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD Ø5.5 SOFT CURV L35 TI

    MDR report key: 3012043 · Received March 20, 2013

    Report

    Report Number
    8030965-2013-01022
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 O.R. 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 IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115426 ROD Ø5.5 SOFT CURV L35 TI NKB SYNTHES GMBH 7574714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention