BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCK-SCREW, REFORM PEDICLE SCRW SYSTEM

    MDR report key: 3065930 · Received April 16, 2013

    Report

    Report Number
    3005739886-2013-00016
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SPINAL USA, INC
    Product Code
    MNI
    PMA / PMN Number
    K121172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION OF THE RETURNED LOCK SCREW NOTED EXTENSIVE DAMAGE TO THE FIRST TWO THREADS CONSISTENT WITH CROSS THREADING. THE OPPOSING THREADS, FOUND TO BE INTACT, WERE CHECKED WITH A MATING PART AND NO ISSUE WAS NOTED WITH THE FIT OF THE THREADS. REVIEW OF RECEIVING INSPECTION REPORTS FOR (B)(4) LOT 0059BG, FOUND A TOTAL OF (B)(4) UNITS OF THIS LOT WERE RECEIVED FROM THE SUPPLIER AND RELEASED FOR DISTRIBUTION IN (B)(4) 2013 WITH NO DEVIATION OR ANOMALIES. REVIEW OF COMPLAINT HISTORY DID NOT FIND ANY ADDITIONAL ISSUES OF THIS NATURE REPORTED FOR THE PART/LOT INVOLVED IN THIS EVENT. THERE WAS ONE ADDITIONAL REPORT OF STRIPPING FOR THIS PART NUMBER WITH A DIFFERENT LOT BUT NO LOOSE METAL SHAVINGS WERE REPORTED. ROOT CAUSE IS ATTRIBUTED TO USER ERROR/SURGICAL TECHNIQUE. ASSOCIATED INSTRUCTIONS FOR USE, REFORM PEDICLE SCREW SYSTEM, STATES UNDER INTRAOPERATIVE:" DURING CONSTRUCT ASSEMBLY DO NOT CROSS THREAD LOCKING CAP SCREWS. ROTATE LOCKING CAP SCREWS COUNTER CLOCK WISE FOR 1 TO 2 REVOLUTIONS IN SCREW HEAD BEFORE ATTEMPTING TO THREAD LOCKING CAP SCREW INTO SCREW HEAD."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6) 2013, UPON ASSEMBLING THE (B)(4) REFORM LOCK-SCREW INTO THE TULIP OF THE REFORM POLYAXIAL PEDICLE SCREW, METAL SHAVINGS PEELED OFF AND HAD TO BE REMOVED FROM PATIENT'S WOUND. THE PROCEDURE WAS COMPLETED USING ANOTHER SET SCREW THAT WAS READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163843 LOCK-SCREW, REFORM PEDICLE SCRW SYSTEM PEDICLE SCREW SYSTEM MNI SPINAL USA, INC 0059BG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention