BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 7019938 · Received November 10, 2017

    Report

    Report Number
    2520274-2017-12619
    Event Type
    Injury
    Date Received
    November 10, 2017
    Report Date
    October 17, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DE RUITER, G., LOBATTO, D., WOLFS, J., PEUL, W., AND ARTS, M. (2014) RECONSTRUCTION WITH EXPANDABLE CAGES AFTER SINGLE- AND MULTILEVEL CORPECTOMIES FOR SPINAL METASTASES: A PROSPECTIVE CASE SERIES OF 60 PATIENTS. THE SPINE JOURNAL, VOLUME 14: 2085-2093. THIS REPORT IS FOR UNKNOWN ¿ SYNEX CAGE/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4). 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 DE RUITER, G., LOBATTO, D., WOLFS, J., PEUL, W., AND ARTS, M. (2014) RECONSTRUCTION WITH EXPANDABLE CAGES AFTER SINGLE- AND MULTILEVEL CORPECTOMIES FOR SPINAL METASTASES: A PROSPECTIVE CASE SERIES OF 60 PATIENTS. THE SPINE JOURNAL, VOLUME 14: 2085-2093. THE PURPOSE OF THIS ARTICLE IS TO DETERMINE LONG-TERM OUTCOME FOR RECONSTRUCTION OF THE SPINE WITH EXPANDABLE CAGES AFTER SINGLE AND MULTILEVEL CORPECTOMIES FOR SPINAL METASTASES. THIS PROSPECTIVE COHORT STUDY OCCURRED BETWEEN DECEMBER 2005 AND MAY 2011, WHERE SIXTY PATIENTS (30 MALES AND 30 FEMALES) WERE TREATED WITH EXPANDABLE CAGES IN A 5-YEAR PERIOD WITH A MAXIMUM FOLLOW-UP OF 6 YEARS. SINGLE-LEVEL RECONSTRUCTION WAS PERFORMED IN 48 CASES, 2-LEVEL IN 8, AND 3-LEVEL IN 4. MEAN AGE WAS 62 YEARS (RANGE 40-70 YEARS). MEAN FOLLOW-UP FOR TWO LEVEL CASES WAS 39 (RANGE 24¿44) MONTHS AND FOR THREE-LEVEL CASES 44 (RANGE 35¿69) MONTHS. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN ¿ SYNEX CAGE AND REFERS TO SIX (6) UNKNOWN PATIENTS EXPERIENCED NEUROLOGIC DETERIORATION. ONE PATIENT EXPERIENCED WEAKNESS OF THE ILIOPSOAS MUSCLE (MRC GRADE 2) AFTER REMOVAL OF AN L2 METASTASIS THROUGH AN ANTEROLATERAL APPROACH. ONE PATIENT, THE SPINAL CORD WAS INJURED DURING SURGERY, WHICH RESULTED IN PARESIS OF THE RIGHT LEG (MRC GRADE 3). TWO PATIENTS HAD TEMPORARY HOARSENESS BECAUSE OF TRACTION INJURY OF THE RECURRENT LARYNGEAL NERVE AND TWO PATIENTS HAD A TRANSIENT HORNER SIGN. AND TEN (10) UNKNOWN PATIENTS HAD CEREBROSPINAL FLUID LEAK (5%), RE-BLEEDING (3%), AND INFECTION (10%). OF THE TEN (10) UNKNOWN PATIENTS IN WHICH THESE COMPLICATIONS OCCURRED, SIX UNKNOWN PATIENTS REQUIRED REOPERATION. AND ONE (1) UNKNOWN PATIENT HAD BRONCHIAL PERFORATION, WHICH OCCURRED MORE THAN 4 YEARS AFTER A THREE-LEVEL CORPECTOMY OF TH4¿TH6 THAT WAS RECONSTRUCTED WITH AN EXPANDABLE CAGE AND ANTERIOR ROD FIXATION. A TRANSTHORACIC REOPERATION WAS PERFORMED WITH RECONSTRUCTION OF THE BRONCHUS AND REMOVING OF THE ANTERIOR PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801774 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention