BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE SPINAL FIXATION SYSTEM

    MDR report key: 282928 · Received June 21, 2000

    Report

    Report Number
    2184052-2000-00005
    Event Type
    Injury
    Date Received
    June 21, 2000
    Date of Event
    May 23, 2000
    Report Date
    June 21, 2000
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY TWO DAYS POST-OP, ONE OF THE SACRAL PEDICLES WAS FRACTURED MEDIALLY; REPORTEDLY DUE TO POOR PLACEMENT OF THE POLYAXIAL SCREW. REMOVAL OF THE SCREW, LOCKING NUT, AND ROD SEGMENT WAS PERFORMED FIVE TO SIX MONTHS LATER, AS THE PT REPORTED INCREASED PAIN. UPON REMOVAL, IT WAS OBSERVED THAT THE POLYAXIAL ASSEMBLY WAS NOT LOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWP SULZER SPINE-TECH NA P990568

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention