BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 3827640 · Received May 22, 2014

    Report

    Report Number
    2530088-2014-10130
    Event Type
    Injury
    Date Received
    May 22, 2014
    Report Date
    May 14, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: (B)(6) 2012. THIS REPORT IS FOR UNKNOWN PRODISCC, UNKNOWN PART/UNKOWN LOT. 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. JUNSEOK W. HUR ET AL (SEPTEMBER, 2012): UNUSUAL FATAL INFECTIONS AFTER ANTERIOR CERVICAL SPINE SURGERIES. KOREAN J. SPINE, 9(3): 304-308. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, "JUNSEOK W. HUR ET AL (SEPTEMBER, 2012): UNUSUAL FATAL INFECTIONS AFTER ANTERIOR CERVICAL SPINE SURGERIES. KOREAN J. SPINE, 9(3): 304-308". A (B)(6) YEAR OLD MALE PRESENTED WITH A C6-C7 DISC HERNIATION RESULTING IN RIGHT ARM RADICULAR PAIN, HE UNDERWENT AN UNCOMPLICATED C6-7 DISCECTOMY AND ARTIFICIAL DISC REPLACEMENT(PRODISC-C). 2 WEEKS LATER, THE PATIENT REPRESENTED WITH SUDDEN NECK PAIN. X-RAY EXAMINATION DEMONSTRATED INSTRUMENT DISPLACEMENT AND SUBSIDENCE. UPON REVISION OF THE PREVIOUS OPERATION SITE, SMALL AMOUNT OF YELLOWISH PUS LIKE DISCHARGE WAS FOUND AT PREVERTEBRAL SPACE JUST ANTERIOR TO C6 AND ARTIFICIAL DISC. CULTURE BIOPSY WAS TAKEN. THE INSTRUMENT WAS REMOVED, FOLLOWED BY MASSIVE IRRIGATION. C6 VERTEBRA BODY SHOWED SOME INFLAMMATION REACTION AND THEREFORE, CORPECTOMY WAS PERFORMED. BONE GRAFT, HARVESTED FROM THE ILIAC CREST, WAS PLACED BETWEEN THE VERTEBRAL BODIES C5/C7, AND AN ANTERIOR PLATE (VECTRA PLATE) WAS APPLIED. VANCOMYCIN WAS STARTED EMPIRICALLY AND (B)(6) WAS ISOLATED FROM THE PUS. BUT WHITE BLOOD CELLS (WBC), C-REACTIVE PROTEIN (CRP), ESTIMATED SEDIMENTATION RATE (ESR) WERE RISING, WOUND WAS UNHEALED, PUS LEAKAGE PERSISTED, AND FEVER DID NOT SUBSIDE. ANTIBIOTIC TREATMENT WAS CHANGED TO TEICOPLANIN ON POSTOPERATIVE DAY 7. ENHANCED MRI WAS PERFORMED ON POSTOPERATIVE DAY 14. EPIDURAL ABSCESS WAS NOTED ON C3-7, RESULTING IN SLIGHT COMPRESSION OF THE CORD. EMERGENCY SURGERY WAS PERFORMED. WE REMOVED THE IMPLANT AND MASSIVE IRRIGATION WAS HELD. BUT 7 DAYS AFTER SURGERY, PATIENT SHOWED SUDDEN WEAKNESS ON RIGHT UPPER EXTREMITY TO GRADE 1. ENHANCED MRI WAS PERFORMED IMMEDIATELY. EPIDURAL ABSCESS SHOWED AGGRAVATION, ASCENDING EXTENSION FROM C7 TO C2 LEVEL. ANOTHER EMERGENCY SURGERY WAS PERFORMED. AT FIRST, C2-6 CORPECTOMY WAS PERFORMED VIA PREVIOUS INCISION. THE ABSCESS WAS DEBRIDED, IRRIGATED AND EVACUATED. SPECIMENS WERE SENT FOR CULTURE. THE PATHOGEN ISOLATED WAS ALSO (B)(6), SO THAT TEICOPLANIN WAS MAINTAINED. WOUND WAS UNCLOSED AND DAILY IRRIGATION WAS PERFORMED. FEW DAYS LATER, ALTERED MENTALITY AND UNSTABLE VITAL SIGN WERE NOTED, AND THE SYMPTOMS CONTINUED FOR MORE THAN A WEEK. PATIENT WAS TREATED IN INTENSIVE CARE UNIT BECAUSE OF BACTERIAL MENINGITIS AND SEPTIC CONDITION. 3 WEEKS AFTER, INFECTION SEEMED TO BE UNDER CONTROL. MENTALITY AND VITAL SIGN IMPROVED. ESR/CRP DROPPED CONTINUOUSLY TILL 44/13.35 AND THERE WAS NO MORE DISCHARGE FROM WOUND. SO WOUND WAS CLOSED UNDER GENERAL ANESTHESIA. AFTER ANOTHER 4 WEEKS OF ABSOLUTE BED REST, WE PERMITTED WALKERASSISTED AMBULATION WITH FOUR POSTER BRACE WEARING. ANTIBIOTICS WERE MAINTAINED FOR ADDITIONAL 2 WEEKS. 2 MONTHS LATER, ESR/CRP DECLINED TO 14/0.7 AND FOLLOW UP MRI REVEALED COMPLETE RESOLUTION OF THE EPIDURAL ABSCESS AND NO FURTHER EVIDENCE OF SPINAL CORD COMPRESSION. THEREFORE, WE ATTEMPT A LAST SURGERY FOR STABILIZATION. THE INITIAL PLAN WAS ANTERIOR AND POSTERIOR FUSION, BUT ANTERIOR SURGICAL PLANE WAS TOO ADHESIVE AND DURAL THINNING WAS NOTED, INDICATING THAT ANTERIOR FUSION HAD FAILED. IN THE POSTERIOR FUSION APPROACH, POLYAXIAL SCREW-ROD SYSTEM WAS USED FOR C2-T2 FIXATION THROUGH THE PEDICLE. A STRONG FRAMEWORK WAS REQUIRED FOR STABILITY DUE TO ANTERIOR FUSION FAILURE. THE PATIENT¿S NEUROLOGY IMPROVED - RIGHT UPPER MOTOR UP TO GRADE 4, AND OTHER MOTOR GRADES 5, AND LABORATORY TESTS ALSO RETURNED TO NORMAL. HE WAS DISCHARGED AND THERE WAS NO ADDITIONAL EVENT DURING OUTPATIENT FOLLOW-UP PERIOD. THIS 1 OF 2 REPORT FOR (B)(4). THIS REPORT FOR UNKNOWN PRODISC-C IMPLANT, UNKNOWN PART#/LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305893 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention