BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIS ROD Ø5.5 RAD 100 CURV L50 TI

    MDR report key: 2954645 · Received February 11, 2013

    Report

    Report Number
    8030965-2013-00384
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K093668
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION HAS SHOWN THAT THE COMPLAINED IMPLANTS PRESENTS SIGNS OF USE SUCH AS MARKS AND SCRATCHES, WHICH AROSE FROM THE HANDLING DURING IMPLANTATION / REMOVAL. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THE CONCERNED LOCKING CAPPEDICLE, THE PEDICLE SCREW AND THE ROD WERE MANUFACTURED IN THE YEAR 2012 ACCORDING TO THE SPECIFICATIONS. UNFORTUNATELY THE EXACT CAUSE OF FAILURE COULD NOT BE DETERMINED. A POSSIBLE FAILURE REASON COULD BE THAT DURING THE FINAL TIGHTENING THE SCREW HEADS WERE NOT PERPENDICULAR TO THE ROD. THE DESIRED ORIENTATION OF THE SCREW HEAD CAN BE ACHIEVED BY A VERTICAL ALIGNMENT OF THE COUNTER TORQUE IN RELATION TO THE ROD.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE LOCKING CAP OF THE MATRIX PEDICLE SCREW BECAME LOOSE. THE DEVICE WAS EXPLANTED ON (B)(6) 2013. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58372 MIS ROD Ø5.5 RAD 100 CURV L50 TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES GMBH 7920701

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention