BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

    MDR report key: 5215539 · Received November 10, 2015

    Report

    Report Number
    2520274-2015-17033
    Event Type
    Injury
    Date Received
    November 10, 2015
    Date of Event
    October 12, 2015
    Report Date
    October 12, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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 CERVICAL SPINE LOCKING PLATE SCREW / UNKNOWN QUANTITY / UNKNOWN LOT. 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 (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 5 OF 6 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN CERVICAL SPINE LOCKING PLATE SCREW AND REFERS TO THE FOLLOWING COMPLICATIONS: 1 PATIENT EXPERIENCED HARDWARE REMOVAL, PULLOUT OF THE LOWER PART OF THE PLATE AND SCREWS AND SETTLING OF THE CAGE INTO THE C6 VERTEBRAL BODY) OCCURRED IN A PATIENT WHO UNDERWENT A C-5 CORPECTOMY. A C-6 CORPECTOMY AND RECONSTRUCTION WITH AN EXPANDABLE CAGE AND PLATE WAS PERFORMED WITH SUPPLEMENTAL POSTERIOR INSTRUMENTATION. ONE PATIENT WHO UNDERWENT 2- LEVEL CORPECTOMY AND POSTERIOR FUSION DEVELOPED PROGRESSIVE NECK PAIN 5 MONTHS POSTOPERATIVELY. IMAGING STUDIES REVEALED FAILURE OF THE PLATE WITH MAINTAINED POSITION OF THE CAGE. SINCE THE CAGE WAS IN A GOOD POSITION, THE PATIENT UNDERWENT REMOVAL OF THE PLATE, ADDITIONAL ARTHRODESIS, AND SUBSEQUENT FUSION, AND HIS NECK PAIN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743355 APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention