BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S 100 PEDICLE SCREW SYSTEM

    MDR report key: 2225705 · Received July 20, 2011

    Report

    Report Number
    3007932279-2011-00001
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 20, 2011
    Manufacturer
    RENOVIS SURGICAL TECHNOLOGIES
    Product Code
    MNI
    PMA / PMN Number
    K101682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION SURGERY, IF NECESSARY, HAS YET TO BE SCHEDULED. MFR WILL F/U WITH ADD'L INFO AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PT CAME INTO CLINIC FOR ROUTINE (B)(6) WEEK F/U VISIT FOR POSTERIOR LUMBAR INSTRUMENTED FUSION L3-L1. SCREWS WERE PLACED IN L3, L4, AND S1 ONLY. BROKEN SCREWS ARE PRESENT IN L5 FROM PREVIOUS TREATMENT. X-RAY REVEALED ONE OF SIX LOCKING CAPS HAD MIGRATED FROM TULIP. TWO WEEKS POST-UP, PT REPORTEDLY HEARD "POP" IN BACK. X-RAY APPEARED NORMAL AT EMERGENCY ROOM VISIT. NO SUPPLEMENTAL INSTRUMENTATION WAS USED. NO POST-OPERATIVE BRACING WAS PRESCRIBED. PT IS PARAPLEGIC WITH A PREVIOUS FAILED FUSION (PSEUDO-ARTHOSIS). REVISION SURGERY IS A POSSIBILITY AT THIS TIME. IF REVISION OCCURS, PRODUCT IS REQUESTED BACK FOR INVESTIGATION ON (B)(4) AND MFR WILL F/U ON MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S 100 PEDICLE SCREW SYSTEM MNI, KWP, MNH MNI RENOVIS SURGICAL TECHNOLOGIES S 100 LOCKING CAP

    Patients

    Seq Age Sex Outcome Treatment
    1