BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIPLATE SELFDRLLING SCW,16MM

    MDR report key: 5183929 · Received October 28, 2015

    Report

    Report Number
    1526439-2015-10882
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    October 1, 2015
    Report Date
    October 1, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWQ
    PMA / PMN Number
    PK042544
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIPLATE 38MM TWO LEVEL PLATE (PRODUCT CODE: 1897-22-038, LOT NUMBER: AMHDJM), THE UNIPLATE 16MM SELF-DRILLING SCREW (PRODUCT CODE: 1897-07-016, LOT NUMBER: AMGDVZ), AND THE TWO UNIPLATE 14MM SELF-DRILLING SCREWS (PRODUCT CODE: 1897-07-014, LOT NUMBER: ANKBV5) WERE RETURNED TO THE COMPLAINTS HANDLING UNIT. THE TWO UNIPLATE 14MM SELF-DRILLING SCREWS (PRODUCT CODE: 1897-07-014, LOT NUMBER: ANKBV5) WERE CONSIDERED CONCOMITANT DEVICES. THERE IS NO INDICATION THAT THE SELF DRILLING BONE SCREWS 4.60MM X 14MM CAUSED OR CONTRIBUTED TO THE EVENT. ALL OF THE PARTS RETURNED FEATURE SIGNS OF USE IN THE FORM OF SURFACE SCRATCHES. THE PLATE IN PARTICULAR FEATURES A NUMBER OF MARKINGS. THE PLATE ALSO FEATURES A LOT OF STRIPPING ON ITS THREE CAMS. HOWEVER, THERE IS NO INDICATION THAT ANY OF THESE CAMS MALFUNCTIONED OR FAILED TO HOLD THE SCREWS IN PLACE. THERE IS ALSO NO DAMAGE TO THE HOLES THROUGH WHICH THE SCREWS ARE PLACED. ALL OF THE THREE RETURNED SELF-DRILLING SCREWS FEATURE SIGNS OF USE IN THE FORM OF WEAR ON THE INSIDE OF THE DRIVE FEATURE. THIS WEAR IS NOT SEVERE ENOUGH TO HAVE STRIPPED THE DRIVE FEATURE TO THE DEGREE THAT IT COULD INTERFERE WITH A DRIVER¿S ABILITY TO INTERACT WITH THE DRIVE FEATURE. THERE IS NO DAMAGE TO THE THREADS OF THE SCREWS THAT WOULD HARM THE MANNER WITH WHICH THE SCREWS INTERACT WITH THE BONE. IT WAS NOTED THAT THE 16MM SCREW WHICH BACKED OUT DID FEATURE NOTABLY MORE WEAR TO ITS DRIVE FEATURE, BUT NO OTHER DAMAGE WAS FOUND. NO DETERMINATION CAN BE MADE INTO THE POSSIBLE CAUSE OF THE PLATE AND SCREW BACKING OUT POSTOPERATIVELY DUE TO THE LACK OF A DISTINCT FORM OF DAMAGE. THE SURFACE MARKINGS AND WEAR ARE NOT SUFFICIENT TO REACH A CONCLUSION INTO A POTENTIAL CAUSE. HOWEVER, THE RETURNED IMAGES ARE SUFFICIENT TO CLEARLY SEE THAT ONE SCREW AND ITS ASSOCIATED END OF THE PLATE DID BACK OUT POSTOPERATIVELY. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. A ROOT CAUSE CANNOT BE DETERMINED FROM THE SAMPLES AND THE INFORMATION PROVIDED. THE SAMPLES WERE NOT SUFFICIENT TO EFFECTIVELY PROVE THAT A SCREW AND PLATE HAD BACKED OUT POSTOPERATIVELY. HOWEVER, THE IMAGES RETURNED CLEARLY SHOW THAT THE SCREW AND PLATE HAVE SEPARATED FROM THE BONE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACDF IMPLANTED ON (B)(6) 2013, C5/6, C6/7 USING UNIPLATE AND DEPUY CERVICAL CAGES. AT REVISION SURGERY ON (B)(6) 2015, ON X-RAY, THE UNIPLATE SCREW AT C5 LEVEL HAD BACKED OUT OF BONE AND PLATE. AT REVISION SURGERY, SURGEON PERFORMED ACDF AT C4/5, AND REMOVED THE UNIPLATE AND SCREWS FROM C5/6, C6/7 AT THIS TIME. THE CAGES WERE LEFT INSITU, THE SURGEON STATED THE PREVIOUS ACDF HAD ACHIEVED BONY FUSION. PHOTOS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714846 UNIPLATE SELFDRLLING SCW,16MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R