BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 5116083 · Received October 1, 2015

    Report

    Report Number
    2520274-2015-16312
    Event Type
    Injury
    Date Received
    October 1, 2015
    Report Date
    September 18, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: WANG, M., KIM, D., & KIM, K. (N.D.). CORRECTION OF LATE TRAUMATIC THORACIC AND THORACOLUMBAR KYPHOTIC SPINAL DEFORMITIES USING POSTERIORLY PLACED INTERVERTEBRAL DISTRACTION CAGES. OPERATIVE NEUROSURGERY 1, 162-172. THIS REPORT IS FOR UNKNOWN SYNEX SYSTEM/UNKNOWN QUANTITY/UNKNOWN LOT. RADICULOPATHY. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 LITERATURE ARTICLE: WANG, M., KIM, D., & KIM, K. (2008). CORRECTION OF LATE TRAUMATIC THORACIC AND THORACOLUMBAR KYPHOTIC SPINAL DEFORMITIES USING POSTERIORLY PLACED INTERVERTEBRAL DISTRACTION CAGES. OPERATIVE NEUROSURGERY 1, 162-172. USA. THE ARTICLE MENTIONS THE SAFETY AND STABILITY OF THORACIC OR THORACOLUMBAR DEFORMITY CORRECTION FROM A SOLELY POSTERIOR APPROACH WITH PLACEMENT OF MODULAR ANTERIOR CAGES AND POSTERIOR SEGMENTAL FIXATION IN ONE OPERATION. TWENTY-EIGHT PATIENTS WHO FAILED BRACE TRIAL FOR 6 MONTHS OR LONGER WERE INCLUDED IN THE SERIES. ALL PATIENTS HAD PROGRESSIVE NEUROLOGICAL DEFICIT AND/OR DEFORMITY PROGRESSION AT TIME OF OPERATION. ALL PATIENTS UNDERWENT A SINGLE OPERATION IN THE PRONE POSITION. SEGMENTAL FIXATION WAS ACCOMPANIED BY ANTERIOR COLUMN RECONSTRUCTION USING MODULAR CAGES AVOIDING NERVE ROOT SACRIFICE. STACKABLE CAGES WERE USED FOR HIGH THORACIC DEFORMITY. SEVENTEEN PATIENTS UNDERWENT EXPANDABLE CAGE CORRECTION VIA THE COSTOTRANSVERSE/LATERAL EXTRACAVITARY APPROACH. THE TELESCOPING SYNEX CAGE (SYNTHES (B)(4)) WAS THEN RATCHETED INTO ITS SHORTEST LENGTH AND INSERTED OBLIQUELY THROUGH THIS LATERAL APPROACH INTO THE INTERBODY SPACE. ELEVEN PATIENTS UNDERWENT STACKABLE CAGE PLACEMENT VIA THE TRANSPEDICULAR OR COSTOTRANSVERSE APPROACH. RADIOLUCENT CARBON- FIBER REINFORCED POLYMER STACKABLE CAGES ((B)(4); DEPUY SPINE, JOHNSON & JOHNSON, (B)(4)) WERE THEN PLACED SERIALLY INTO THE INTERVERTEBRAL SPACE AND ASSEMBLED IN SITU. THE TRAVERSING NERVE ROOT WAS PRESERVED. THIS REPORT REFERS TO COMPLICATIONS IN A (B)(6) FEMALE WHO WAS NOTED TO HAVE A NEW RADICULOPATHY AT THE SITE OF GRAFT PLACEMENT ON POSTOPERATIVE DAY 1 WITH BENIGN COMPUTED TOMOGRAPHIC FINDINGS. AT 6 MONTHS, THE PATIENT ACKNOWLEDGED PERSISTENCE OF NUMBNESS BUT DENIED DISCOMFORT. THIS IS REPORT 5 OF 6 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651715 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention