BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 5604599 · Received April 25, 2016

    Report

    Report Number
    2520274-2016-12148
    Event Type
    Injury
    Date Received
    April 25, 2016
    Report Date
    April 4, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CLARKE, M. J. ET AL, (2015) FUSION FOLLOWING LATERAL MASS RECONSTRUCTION IN THE CERVICAL SPINE. J NEUROSURG SPINE, 22:1477-9. THIS REPORT IS FOR AN UNKNOWN ROD/UNKNOWN QUANTITY/UNKNOWN LOT. UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). 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: CLARKE, M. J. ET AL, (2015) FUSION FOLLOWING LATERAL MASS RECONSTRUCTION IN THE CERVICAL SPINE. J NEUROSURG SPINE, 22:1477-9. USA ARTICLE. THIS ARTICLE PRESENTED 7 CASES IN WHICH LATERAL MASS RECONSTRUCTION WITH A CAGE OR FIBULAR STRUT GRAFT WAS USED TO PROVIDE LOAD-BEARING SUPPORT, INCLUDING 1 CASE OF BILATERAL CAGE PLACEMENT. A RETROSPECTIVE REVIEW WAS PERFORMED OF THE MEDICAL RECORDS OF ALL 7 PATIENTS WHO UNDERWENT LATERAL MASS CAGE PLACEMENT OR FIBULAR STRUT GRAFTING FROM 2007 TO 2009 AT 2 ACADEMIC INSTITUTIONS. CAGES WERE SECURED WITH SMALL FRAGMENT SCREWS (SYNTHES). FOUR MEN (57%) AND 3 WOMEN (43%) WITH AN AVERAGE AGE OF 49 YEARS (RANGE 16-77 YEARS) WERE TREATED. A NEOPLASTIC PROCESS WAS DIAGNOSED IN ALL PATIENTS. CASE 2: THIS WAS (B)(6) WOMAN WHO PRESENTED WITH NECK PAIN. MRI AND CT SCANS AND A BIOPSY SAMPLING CONFIRMED A C2-4 CHONDROSARCOMA. SHE UNDERWENT A 3-STAGE ENBLOC RESECTION. THE SYNTHES DEVICES IMPLANTED IN THIS PATIENT INCLUDE: SYNMESH CAGE, SYNASPE SCREWS AND SMALL FRAGMENT SCREWS. COMPLICATIONS INCLUDE: FOURTEEN MONTHS AFTER SURGERY THE PATIENT HAD ACUTE NECK PAIN, DIFFICULTY SWALLOWING, A NEW NECK DEFORMITY, POSTERIOR ROD FRACTURE (MANUFACTURER NOT IDENTIFIED IN ARTICLE) WITH REMOVAL OF POSTERIOR INSTRUMENTATION WITH REINFORCEMENT OF THE CONSTRUCT. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR: UNKNOWN ROD, UNKNOWN QUANTITY AND UNKNOWN LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258831 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention