BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM

    MDR report key: 5915823 · Received August 30, 2016

    Report

    Report Number
    2520274-2016-14392
    Event Type
    Injury
    Date Received
    August 30, 2016
    Report Date
    August 22, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    PMA / PMN Number
    K071667
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DATE OF IMPLANT IS UNKNOWN AND WAS REPORTED ONLY AS AN UNKNOWN DATE IN 2006. (B)(4). THIS EVENT RESULTED IN PAIN, DIFFICULTY SWALLOWING, ESOPHAGEAL TEAR, AND REQUIRED ADDITIONAL SURGICAL INTERVENTION TO REMOVE THE HARDWARE, AND REPAIR THE ESOPHAGEAL TEAR. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: APPROXIMATELY 10 YEARS FOLLOWING A C5-T1 ANTERIOR CERVICAL FUSION, THE PATIENT PRESENTED WITH SWALLOWING DIFFICULTIES AND SHARP PAIN. MRI IMAGING SHOWED THE PLATE AND SCREWS TO BE SITTING PROUD OF THE PATIENT¿S ANATOMY. A REVISION SURGERY WAS PERFORMED TO REMOVE THE CONSTRUCT AND REPAIR A TORN ESOPHAGUS. THE 3 LEVEL/51MM VECTRA PLATE (04.613.251) IS A COMPONENT OF THE VECTRA SYSTEM WHICH IS INTENDED FOR ANTERIOR PLATE AND SCREW FIXATION OF THE CERVICAL SPINE (C2-C7). THE PLATES FEATURE WISHBONE CLIPS WHICH INTERACT WITH A GROVE IN THE SYSTEM¿S SCREWS IN ORDER TO LOCK THEM TO THE PLATE AND PREVENT BACK-OUT. THE RETURNED PLATE (04.613.251) AND SCREWS (04.613.516 X8) WERE EXAMINED AND NO DEFECTS OR DEFICIENCIES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION OF SCREW MIGRATION/BACK OUT. MINOR WEAR AND DISCOLORATION WERE NOTED CONSISTENT WITH IMPLANTATION/EXPLANTATION. AS NO DAMAGE POTENTIALLY RELATED TO THE COMPLAINT CONDITION WAS NOTED ON THE RETURNED DEVICES, THE COMPLAINT CONDITION IS UNABLE TO BE CONFIRMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED 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

    IT WAS REPORTED THAT ORIGINAL PROCEDURE FOR ANTERIOR CERVICAL FUSION FROM C5-T1 WAS PERFORMED ON AN UNKNOWN DATE IN 2006. POST-OPERATIVELY DUE TO PATIENT COMPLAINING OF SWALLOWING DIFFICULTIES, SHARP PAIN, LOOSENING AND THE MAGNETIC RESONANCE IMAGING (MRI) SHOWED THE PLATE AND SCREWS SITTING PROUD. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO EXPLANTS, A VECTRA PLATE AND EIGHT (8) SELF-DRILLING VECTRA SCREWS. THE SURGEONS BELIEVE THAT THE SCREWS AND PLATE CAUSED THE TEAR IN THE PATIENT ESOPHAGUS. THE PLATE AND SCREWS WERE SUCCESSFULLY REMOVED INTACT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA AS A RESULT OF THE EVENT. ADDITIONALLY, IT WAS REPORTED THAT EARS, NOSE, AND THROAT (ENT) SURGEONS WERE IN THE OPERATING ROOM AS WELL TO REPAIR THE TEAR IN THE ESOPHAGUS. THIS COMPLAINT INVOLVES NINE PARTS. THIS REPORT IS 7 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566265 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention