BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.8MM TI LOCKING SCREW

    MDR report key: 3120033 · Received May 20, 2013

    Report

    Report Number
    2520274-2013-02702
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KWP
    PMA / PMN Number
    K994187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DESIGN EVALUATION WAS CONDUCTED. THE CERVICAL SPINE LOCKING PLATE SYSTEM, CSLP, INCLUDES VARIABLE ANGLE PLATES THAT USE EXPANSION HEAD SCREWS AND LOCKING SCREWS. THE EXPANSION HEAD SCREWS SECURE THE PLATE TO THE ANTERIOR ASPECT OF THE CERVICAL SPINE. THE LOCKING SCREWS SECURE THE EXPANSION HEAD SCREWS TO THE PLATE. ASSOCIATED DRAWINGS WERE REVIEWED. THESE DRAWINGS DETAIL THE APPROPRIATE DIMENSIONS, MATERIALS, AND FINISHING PROCESSES FOR A SUCCESSFUL CONSTRUCT. THE RETURNED SCREW ASSEMBLY WAS PLACED IN BOTH POSSIBLE ¿UPPER RIGHT¿ HOLES. THE SCREWS APPEARED TO FIT AS INTENDED. THE RISK ANALYSIS FOR THE CSLP SYSTEM WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE HAZARD OF THIS COMPLAINT. THE RETURNED PARTS APPEAR TO FUNCTION AS INTENDED AND THE ROOT CAUSE OF THE SCREW PULL OUT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN INITIAL SPINAL FUSION SURGERY ON (B)(6) 2012 FROM C3 TO C6. AN X-RAY TAKEN ON AN UNKNOWN DATE REVEALED THAT A SCREW SEEN IN THE UPPER RIGHT HOLE OF THE CERVICAL SPINE LOCKING PLATE WAS BACKING OUT. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM ON (B)(6) 2013, FOR REVISION SURGERY. THE CERVICAL SPINE LOCKING PLATE (CSLP) PLATE, 8 LOCKING SCREWS AND 8 CANNULATED SCREWS WERE REMOVED AND REPLACED WITH A SHORTER SYNTHES CSLP PLATE, 7 QUICK LOCKING SCREWS, 1 CANNULATED SCREW AND 1 LOCKING SCREW. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222089 1.8MM TI LOCKING SCREW KWP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention