BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANG

    MDR report key: 2823691 · Received October 10, 2012

    Report

    Report Number
    8030965-2012-01014
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE SCREWS WERE RECEIVED IN A CONDITION WHERE THEY WERE ASSEMBLED TO THE PLATE. THERE WERE SOME SMALL GOUGES NEAR THE SURFACE OF THE STARDRIVE RECESS OF THE SCREWS. THE DAMAGE WAS CONSIDERED MINOR BECAUSE IT DID NOT AFFECT THE FUNCTION OF THE SCREW; THE SCREWS COULD BE SUCCESSFULLY RETAINED BY THE ZERO-P SCREWDRIVER (03.617.904 LOT #3257545). OTHER THAN THE GOUGES, THERE WAS NO OTHER DAMAGE NOTED ON THE SCREWS. THE IMPLANT IS DESIGNED TO HAVE A SEMI-RIGID CONNECTION BETWEEN THE INTERBODY PLATE AND SPACER. THE INTENT FOR THIS DESIGN WAS TO DECOUPLE THE INTERBODY PLATE FROM THE SPACER, SO THE INTERBODY PLATE COULD PERFORM SIMILAR TO AN ANTERIOR INTERBODY PLATE, AND THE SPACER COULD PERFORM SIMILAR TO AN INTERBODY SPACER. THIS "DECOUPLED" DESIGN SCHEME IS MEANT TO MINIMIZE THE STRESS AND PROMOTE LOAD SHARING BETWEEN THE INTERBODY PLATE AND SPACER. THUS, THE INTERBODY PLATE AND SPACER WERE DESIGNED AS SEPARATE PARTS THAT HAVE COMPLIMENTARY MATING FEATURES THAT ARE KEYED TO ONLY ASSEMBLE IN ONE VERTICAL DIRECTION. IMPLANTS WITH SMALLER HEIGHTS (I.E. 5 AND 6MM) CAN BE MORE SUSCEPTIBLE TO DISASSEMBLY BECAUSE THE COMPLIMENTARY MATING FEATURES ARE SLIGHTLY SMALLER IN THE VERTICAL DIRECTION. IN ADDITION, THE HOLE PREP AND SCREW INSERTION INSTRUMENTS ARE DESIGNED TO INSERT SCREWS WITHIN A SPECIFIC RANGE. IF THESE INSTRUMENTS ARE MISUSED OUTSIDE OF THE RANGE, IT COULD CREATE AN ENVIRONMENT THAT COULD CAUSE THE INTERBODY PLATE TO SEPARATE FROM THE SPACER.

    Additional Manufacturer Narrative · 1

    DEVICE USED AS TREATMENT. NO VISIBLE DAMAGES, EXCEPT SOME SIGNS OF USE AT THE STARDRIVE RECESS. A VISUAL INSPECTION WAS PERFORMED AND NO ABNORMALITY WAS FOUND. A FUNCTION TEST HAS SHOWN THAT THE SCREW COULD BE INSERTED INTO THE IMPLANT AS REQUIRED. THE SCREW IS LOCKED IN PLACE AS DESIGNED AND HAS STILL THE REQUIRED PLAY FOR THE VARIABLE ANGLE. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    PATIENT PREVIOUSLY FUSED AT C5-C6 AND C6-C7 WITH COMPETITOR'S PRODUCT, DEVELOPED ADJACENT LEVEL DISEASE AT C7-T1. SURGEON WAS IMPLANTING ZERO-P IMPLANT AT C7-T1 AND THE PLATE DETACHED FROM THE PEEK IMPLANT. THE SURGEON WAS UNABLE TO DETERMINE IF THE SCREWS CAUSED THE ISSUE. THE PEEK IMPLANT, SCREWS AND CHRONOS WERE REMOVED AND A NEW PEEK IMPLANT WAS PLACED WITH NO FURTHER INCIDENT. THIS REPORT IS #2 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANG 3.7 TI CERV SPINE SCREW SLF-TPNG/VAR ANGLE 12MM KTT SYNTHES GMBH 7676793

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR SCREW| IMPLANT