BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 5215440 · Received November 10, 2015

    Report

    Report Number
    2520274-2015-17017
    Event Type
    Injury
    Date Received
    November 10, 2015
    Report Date
    October 12, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BERIL G ET AL (2008) SURGICAL TREATMENT OF CERVICAL SPONDYLOTIC MYELOPATHY WITH ANTERIOR COMPRESSION: A REVIEW OF 67 CASES. J NEUROSURG SPINE 9:152¿157. USA. THIS REPORT IS FOR AN UNKNOWN SYN-MESH CAGE / UNKNOWN QUANTITY / UNKNOWN LOT. ONE PATIENT EXPERIENCED POSTOPERATIVE UNILATERAL DELTOID WEAKNESS THAT RESOLVED WITHIN 10 WEEKS OF OPERATION. THREE PATIENTS EXPERIENCED ADJACENT-SEGMENT DISEASE. ONE PATIENT ONE PATIENT REQUIRED RE-EXPLORATION FOR REPAIR OF PSEUDOMENINGOCELE AFTER ANTERIOR SURGERY. ONE PATIENT WHO UNDERWENT A SINGLE LEVEL ACDF, UNDERWENT POSTERIOR DECOMPRESSION AND INSTRUMENTATION FOR ADJACENT LEVEL STENOSIS 4 YEARS LATER AND HAS REMAINED IN STABLE CONDITION FOR 2 MONTHS SINCE. ONE PATIENT WHO UNDERWENT 2 LEVEL ACDF DEVELOPED ADJACENT ¿SEGMENT DISEASE 2 YEARS LATER AND UNDERWENT SINGLE LEVEL ADJACENT SEGMENT ACDF AND REMAINED IN STABLE CONDITION FOR 1 MONTH AT FOLLOW UP. ONE PATIENT WHO UNDERWENT SINGLE LEVEL ACDF WAS FOUND TO HAVE KYPHOTIC DEFORMITY AT THE ADJACENT LEVEL 3 YEARS POSTOPERATIVELY AND UNDERWENT POSTERIOR FUSION AND HAS REMAINED IN STABLE FOR CONDITION FOR 2 MONTHS POSTOPERATIVELY. 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 SUBSEQUENT REVIEW AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: BERIL G ET AL (2008) SURGICAL TREATMENT OF CERVICAL SPONDYLOTIC MYELOPATHY WITH ANTERIOR COMPRESSION: A REVIEW OF 67 CASES. J NEUROSURG SPINE 9:152-157. USA CASES WERE REVIEWED INVOLVING PATIENTS WITH CERVICAL SPONDYLOTIC MYELOPATHY TREATED VIA AN ANTERIOR APPROACH, PAYING SPECIAL ATTENTION TO NEUROLOGICAL OUTCOME, FUSION RATES, AND COMPLICATIONS. RETROSPECTIVELY, 67 CASES INVOLVING PATIENTS WITH CERVICAL SPONDYLOTIC MYELOPATHY REQUIRING AN ANTERIOR DECOMPRESSION WERE REVIEWED: 46 PATIENTS, 21 MEN AND 25 WOMEN, RANGING IN AGE FROM 31 TO 79 YEARS OF AGE, WO UNDERWENT ANTERIOR SURGERY ONLY (1- TO 3-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION [ACDF] OR 1-LEVEL CORPECTOMY), AND 21 PATIENTS, 12 MEN AND 9 WOMEN, RANGING IN AGE FROM 36 TO 67 YEARS, WHO REQUIRED 3-LEVEL ACDF OR 2-LEVEL CORPECTOMY UNDERWENT ANTERIOR SURGERY SUPPLEMENTED BY A POSTERIOR INSTRUMENTED FUSION PROCEDURE. FOR CORPECTOMY PROCEDURES, RECONSTRUCTION AND ARTHRODESIS WAS PERFORMED USING TITANIUM CAGES (SYNMESH, SYNTHES OR COMPETITOR PRODUCT) FILLED WITH LOCAL AUTOGRAFT, ALLOGRAFT, AND BONE PUTTY. ANTERIOR PLATING (CSLP SMALL STATURE AND VARIABLE ANGLE, SYNTHES) WAS USED IN ALL DISCECTOMY AND CORPECTOMY CASES. VARIABLE ANGLE SCREWS WERE USED WITH ALL ANTERIOR PLATES. THIS IS REPORT IS 1 OF 6 FOR (B)(4). THIS IS FOR AN UNKNOWN SYN-MESH CAGE AND REFERS TO THE FOLLOWING COMPLICATIONS: ONE PATIENT UNDERWENT REOPERATION FOR AN EPIDURAL HEMATOMA. ONE PATIENT EXPERIENCED POSTOPERATIVE UNILATERAL DELTOID WEAKNESS THAT RESOLVED WITHIN 10 WEEKS OF OPERATION. THREE PATIENTS EXPERIENCED ADJACENT-SEGMENT DISEASE. ONE PATIENT DEVELOPED INFECTION THAT WAS SUCCESSFULLY TREATED WITH A SINGLE DEBRIDEMENT PROCEDURE. ONE PATIENT ONE PATIENT REQUIRED RE-EXPLORATION FOR REPAIR OF CEREBROSPINAL FLUID FISTULA AND PSEUDOMENINGOCELE AFTER ANTERIOR SURGERY. ONE PATIENT WHO UNDERWENT A SINGLE LEVEL ACDF, UNDERWENT POSTERIOR DECOMPRESSION AND INSTRUMENTATION FOR ADJACENT LEVEL STENOSIS 4 YEARS LATER AND HAS REMAINED IN STABLE CONDITION FOR 2 MONTHS SINCE. ONE PATIENT WHO UNDERWENT 2 LEVEL ACDF DEVELOPED ADJACENT-SEGMENT DISEASE 2 YEARS LATER AND UNDERWENT SINGLE LEVEL ADJACENT SEGMENT ACDF AND REMAINED IN STABLE CONDITION FOR 1 MONTH AT FOLLOW UP. ONE PATIENT WHO UNDERWENT SINGLE LEVEL ACDF WAS FOUND TO HAVE KYPHOTIC DEFORMITY AT THE ADJACENT LEVEL 3 YEARS POSTOPERATIVELY AND UNDERWENT POSTERIOR FUSION AND HAS REMAINED IN STABLE FOR CONDITION FOR 2 MONTHS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743633 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention