BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 5604849 · Received April 25, 2016

    Report

    Report Number
    2520274-2016-12223
    Event Type
    Injury
    Date Received
    April 25, 2016
    Report Date
    April 18, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HASCHTMANN, D., STAHEL, P., HEYDE, C., (2009) MANAGEMENT OF A MULTIPLE TRAUMA PATIENT WITH EXTENSIVE INSTABILITY OF THE LUMBAR SPINE AS A RESULT OF A BILATERAL FACET DISLOCATION AND MULTIPLE COMPLETE VERTEBRAL BURST FRACTURES, J TRAUMA, 66: 992-930. THIS REPORT IS FOR AN UNKNOWN SYNMESH CAGE, /UNKNOWN QUANTITY/UNKNOWN LOT. NO PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE 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 ARTICLE: HASCHTMANN, D., STAHEL, P., HEYDE, C., (2009) MANAGEMENT OF A MULTIPLE TRAUMA PATIENT WITH EXTENSIVE INSTABILITY OF THE LUMBAR SPINE AS A RESULT OF A BILATERAL FACET DISLOCATION AND MULTIPLE COMPLETE VERTEBRAL BURST FRACTURES, J TRAUMA, 66: 992-930. (B)(6). THIS ARTICLE PRESENTED THE TREATMENT AND MANAGEMENT OF A PATIENT WITH MULTIPLE INJURIES WHO SUSTAINED A SUBSTANTIALLY UNSTABLE MULTIPLE LEVEL FRACTURE-DISLOCATION OF THE LUMBAR SPINE AFTER FALL FROM HEIGHT. THE CASE REPORT INVOLVED A (B)(6) WOMAN WHO PRESENTED AFTER SUICIDE ATTEMPT WITH FALL FROM HEIGHT. INITIALLY, SHE WAS AWAKE AND ALERT WITH A GLASGOW COMA SCALE SCORE OF 15, PARAPLEGIA OF THE LEGS AND PAIN IN THE LOWER BACK. SHE SUSTAINED AN IRREDUCIBLY LOCKED FRACTURE-DISLOCATION OF TH12/L1, A VERTEBRAL BODY BURST-SPLIT AND VERTICAL LAMINAR FRACTURE OF L3, AND A COMPLETE BURST FRACTURE OF L4 LEADING TO A SUBSTANTIALLY UNSTABLE LUMBAR SPINE WITH A 90% COMPROMISE OF THE SPINAL CANAL, A CIRCUMFERENTIAL DURAL TEAR, AN AMPUTATION OF THE NERVE ROOTS L4 AND L5 BILATERALLY AND A MASSIVE RETROPERITONEAL HEMATOMA WAS PRESENT. HER TREATMENT PLAN INCLUDED POSTERIOR LUMBAR STABILIZATION (TH12-S1) AND ANTERIOR CORPECTOMY OF L4 AND BI-SEGMENTAL FUSION. IN THE FIRST PROCEDURE A LAMINECTOMY, DECOMPRESSION OF NEURAL STRUCTURES, AND OPEN REDUCTION WITH POSTERIOR INSTRUMENTATION WERE PERFORMED USING A ROD PEDICLE SCREW SYSTEM. IN THE SECOND PROCEDURE A CORPECTOMY OF L4, ANTERIOR DECOMPRESSION AND BI-SEGMENTAL FUSION FROM L3 TO L5 USING A CYLINDRICAL TITANIUM MESH CAGE (SYNMESH, SYNTHES) FILLED WITH AUTOLOGOUS BONE GRAFT (B) WERE PERFORMED. POSTOPERATIVELY FOR BACK PAIN THE PATIENT WAS TREATED WITH DICLOFENAC AND BUPRENORPHINE TTS. AT THE THREE MONTH FOLLOW-UP, THE PATIENT WAS ABLE TO WALK WITH AN ASSISTIVE DEVICE. X-RAY FILMS SHOWED A STABLE INSTRUMENTATION WITH THE SPLIT-BURST-TYPE FRACTURE OF L3 BEING CONSOLIDATED WITHOUT SUBSIDENCE OF THE CAGE INTO THE INITIALLY SPLIT INFERIOR ENDPLATE OF L3. COMPLICATION: POSTOPERATIVE PAIN. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN SPINE (SYNMESH CAGE), UNKNOWN QUANTITY AND LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258690 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention