BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERBOLD SPINAL SCREW SYSTEM

    MDR report key: 1812312 · Received August 17, 2010

    Report

    Report Number
    3005882106-2009-00001
    Event Type
    Injury
    Date Received
    August 17, 2010
    Report Date
    July 28, 2009
    Manufacturer
    VERTIFLEX, INCORPORATED
    Product Code
    NQP
    PMA / PMN Number
    K073143
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW, ROD, AND LOCKING CAP WERE RETURNED FOR EXAMINATION, AT WHICH TIME NO ABNORMALITIES, DAMAGE OR WEAR OTHER THAN THAT NORMALLY EXPECTED FROM 4 MONTHS IN SITU WERE OBSERVED. SALES REP., WHO WAS IN ATTENDANCE DURING SURGERY, REPORTS THAT THE ROD ON ONE SIDE WAS A 120MM ROD CUT TO SIZE AND WAS PLACED THROUGH A MINI-OPEN PROCEDURE. THE ROD ON THE OTHER SIDE WAS PLACED PERCUTANEOUSLY, BUT PHYSICIAN USED INCORRECT TECHNIQUE TO MEASURE APPROPRIATE ROD LENGTH. AS A RESULT, THE SELECTED ROD (60MM) WAS 5-10MM TOO SHORT TO SPAN THE ENTIRE TWO-LEVEL CONSTRUCT. WHEN PLACED, THE ROD WAS LIKELY TOO SHORT TO SEAT FULLY IN THE CEPHALAD SCREW, AND HENCE, WAS NOT SECURELY CAPTURED BY THE LOCKING CAP. IT IS MFR'S OPINION THAT , UNDER FLEXION, THE IMPROPERLY-SEATED ROD END DISENGAGED FROM THE SCREW.

    Description of Event or Problem · 1

    APPROX FOUR (4) MONTHS FOLLOWING IMPLANTATION OF A TWO-LEVEL CONSTRUCT (L4-S1), THE PT BENT OVER AND FELT A "POP". SUBSEQUENT RADIOGRAPHY SUGGESTED THAT A ROD HAD FAILED. AT REVISION SURGERY ON (B)(6), 2009, IT WAS OBSERVED THAT THE CEPHALAD END OF ONE ROD HAD NOT BROKEN, BUT HAD PULLED LOOSE FROM THE L4 SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERBOLD SPINAL SCREW SYSTEM 888.3070 PEDICLE SCREW SPINAL SYSTEM NQP VERTIFLEX, INCORPORATED 60 MM DYNABOLT ROD 080809

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R