BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3781405 · Received April 30, 2014

    Report

    Report Number
    2520274-2014-11132
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 2, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 1 VECTRA PLATE PART AND LOT NUMBER UNKNOWN WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THE PATIENT HAD UNDERGONE SURGERY ON UNKNOWN DATE IN 2013 FOR A C3-C6 ANTERIOR CERVICAL DISCECTOMY AND FUSION UTILIZING VECTRA PLATES AND SCREWS, PLUS A NON-SYNTHES CAGE. ON (B)(6) 2014, AT A POST-OPERATIVE VISIT, THE SURGEON INDICATED THE PATIENT HAD BEEN NON-COMPLIANT IN WEARING THE HARD NECK COLLAR BRACE. FROM A REVIEW OF X-RAYS, TAKEN (B)(6) 2014, THE SURGEON FOUND TWO 4.0X14MM VARIABLE ANGLE SELF-DRILLING SCREWS AT C3 HAD PULLED OUT OF THE VERTEBRAE. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2014 FOR A REVISION ANTERIOR CERVICAL DISCECTOMY AND FUSION BECAUSE OF TWO (2) 4.0X14MM VARIABLE ANGLE SELF-DRILLING SCREWS AND SUPERIOR VECTRA PLATE AT C3 BACKING OUT OF THE VERTEBRAE. THE REPORTED INFORMATION INDICATED 2 SCREWS WERE BROKEN AND EXPLANTED, THE CAGE AND PLATE REMAIN IMPLANTED. AT THE (B)(6) 2014 REVISION SURGERY, THE SURGEON REMOVED THE TWO MIGRATED SCREWS, AND REPLACED THEM WITH TWO LONGER VECTRA SELF-DRILLING VARIABLE ANGLE SCREWS TO REDUCE THE PLATE BACK INTO ALIGNMENT AND LOCATE THE CAGE FURTHER INTO THE VERTEBRAL BODY. THE SURGEON ALSO USED 1CC DBX PUTTY ALLOGRAFT. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED. NO SURGICAL DELAY WAS REPORTED AND REPORTED PATIENT OUTCOME WAS POSITIVE. THE SYNTHES MEDICAL DIRECTOR REVIEWED THE X-RAYS AND REPORTED THE FOLLOWING: FOUR IMAGES HAVE BEEN PROVIDED FOR THIS REVIEW, ALL OF THEM ARE X-RAYS OF CERVICAL SPINE WITH ONE AP VIEW AND THREE LATERAL VIEWS. ONE OF THEM SEEMS LIKE A FLUOROSCOPE IMAGE WITH POOR QUALITY. AN ANTERIOR CERVICAL PLATE APPEARS IMPLANTED FROM C3 TO C6 LEVEL WITH SCREWS INSERTED THROUGH THE PLATE TO C3-C6 VERTEBRAL BODIE (VB). THE SCREW TIPS AT C4-C6 LEVEL POSITION AT THE POSTERIOR 1/3 PART OF THE VBS, WHEREAS C3 SCREW TIPS ONLY POSITION AT THE ANTERIOR 1/3 TO 1/4 PART OF THE VB. IT SEEMS THERE IS A GAP BETWEEN THE POSTERIOR EDGE OF THE PLATE AND THE ANTERIOR EDGE OF C3 VB, WHICH IS INDICATING THE PLATE BACKING OUT OF THE C3 VB. EACH INTERVERTEBRAL DISC SPACE FROM C3/4 TO C5/6 IS FILLED WITH A CAGE DEVICE WITH THREE RADIOPAQUE MARKERS IN IT. A SLIGHT RETROLISTHESIS OF C3 AGAINST C4 APPEARS IN THE LATERAL VIEWS. THIS REPORT IS FOR 1 VECTRA PLATE PART AND LOT NUMBER UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260673 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention