BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI CERVICAL SPINE LOCKING PLATE 22MM (14MM)

    MDR report key: 2863980 · Received December 10, 2012

    Report

    Report Number
    2530088-2012-01062
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K031276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED. THE PART WAS RECEIVED WITH NICKS/SCRATCHES. INTERNAL DIAMETERS OF THE HOLES WERE MEASURED. ONE 12 DEGREE HOLE HAS INTERNAL DAMAGE, RADIAL SCRATCHES THAT ARE NOT ALIGNED TO THE ANGLE OF THE HOLE. THIS DAMAGED HOLE WILL NOT ACCEPT THE GO MEMBER OF ATTRIBUTE GAGE. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. THE RAW MATERIAL WAS CONFIRMED AS CORRECT IN THE DEVICE HISTORY RECORD. OF NOTE, IT WAS NOT REPORTED IF THE CSLP PLATE HOLDING DRILL GUIDE WAS USED WHEN DRILLING THE HOLES. A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. THE PLATE SHOWS SOME MINOR SCRATCHES ON THE TOP SURFACE. THERE ARE NO VISUAL NON-CONFORMANCES TO THE PRODUCT. PRODUCT DEVELOPMENT WAS ABLE TO DETERMINE THAT ONE OF THE HOLES IS OUT OF SPECIFICATION. THE THRU HOLE SHOULD MEASURE 4.5MM AND USING CALIBRATED GAUGE PINS ((B)(4)) THE CAUDAL LEFT HOLE APPEARS TO BE 4.26MM IN DIAMETER. THIS EVENT IS CAPTURED ON THE LATEST VERSION OF THE RISK ANALYSIS.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THERE WERE NO ABNORMALITIES OBSERVED DURING THE DEVICE HISTORY RECORD REVIEW. NOTE: THIS DEVICE IS USED FOR TREATMENT.

    Description of Event or Problem · 1

    DURING INSERTION OF TWO EXPANSION HEAD SCREWS INTO A CSLP GOLD PLATE FOR AN ACDF AT C6-C7, THE TWO SCREWS WOULD NOT FIT THROUGH THE PLATE. SURGEON REMOVED THE CSLP GOLD PLATE AND USED A CSLP VARIABLE ANGLE PLATE WHICH WAS IMPLANTED WITHOUT ISSUE. THE SAME TWO EXPANSION HEAD SCREWS THAT WOULD NOT FIT THROUGH THE CLP GOLD PLATE WERE IMPLANTED INTO THE CSLP VARIABLE ANGLE PLATE WITHOUT ISSUE. ALL SCREWS SEATED CORRECTLY AND THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM.THIS IS THE 1ST OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI CERVICAL SPINE LOCKING PLATE 22MM (14MM) CERVICAL SPINE LOCKING PLATE NKB SYNTHES BRANDYWINE A4GM174

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR SCREWS