BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILVERBOLT PEDICLE SCREW SYSTEM

    MDR report key: 1610820 · Received February 3, 2010

    Report

    Report Number
    3005882106-2009-00003
    Event Type
    Other
    Date Received
    February 3, 2010
    Date of Event
    June 25, 2009
    Report Date
    February 3, 2009
    Manufacturer
    VERTIFLEX, INC.
    Product Code
    NQP
    PMA / PMN Number
    K062670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CAP/SET SCREW WAS RECEIVED BY MFR IN (B)(4) ENVELOPE ON (B)(6) 2009. CAP APPEARS CLEAN, UNDAMAGED, AND INTACT. OF NOTE, HOWEVER, IS THAT A FRAGMENT OF WHAT APPEARS TO BE THE TOP EDGE OF A SCREW SEAT IS LODGED BETWEEN THE LOCKING WINGS OF THE CAP ON ONE SIDE. INSPECTION SUGGESTS THIS FRAGMENT SHEARED OR WAS FRACTURED OFF THE SCREW DURING TIGHTENING OF THE CAP/SET SCREW, AND BECAME LODGED BETWEEN THE WINGS. IF THE SCREW WAS DAMAGED IN THIS FASHION, IT WOULD EXPLAIN WHY SUBSEQUENT ATTEMPTS TO SEAT SEVERAL CAPS FAILED. IT IS MFR'S OPINION THAT THE DAMAGED SCREW, IF IT STILL RESIDES IN SITU, MAY BE SUFFICIENTLY DAMAGED AS TO COMPROMISE CONSTRUCT SECURITY. CLINICIAN HAS BEEN ADVISED OF THESE FINDINGS, AND STATES THAT PT IS DOING FINE BUT WILL BE MONITORED CLOSELY.

    Description of Event or Problem · 1

    IN A PERCUTANEOUS INSTRUMENTATION, A 60MM ROD WAS USED ON THE FIRST SIDE (PT'S RIGHT). WHEN INSERTING THE S1 CAP, IT WOULD "POP UP" WHEN FINAL TIGHTENING AND 3 CAPS APPEARED SHEARED OR BROKEN. INCISION WAS WIDENED TO PERMIT INSERTION AND FINAL TIGHTENING OF S1 CAP. ONE CAP RETURNED TO MFR. FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERBOLT PEDICLE SCREW SYSTEM 888.3070, PEDICLE SCREW SPINAL SYSTEM NQP VERTIFLEX, INC. CAP/SET SCREW 080962

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other