BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 7019953 · Received November 10, 2017

    Report

    Report Number
    2520274-2017-12618
    Event Type
    Injury
    Date Received
    November 10, 2017
    Report Date
    October 17, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. PATIENT CODE (B)(4) REFERS TO SEVERE KYPHOSIS AND A PATIENT THAT WAS RE-OPERATED SEVERAL DAYS LATER AND ANOTHER PATIENT THAT HAD PROGRESSIVE KYPHOSIS AFTER A TWO-LEVEL CORPECTOMY OF C5¿C6 WITH POSTERIOR FIXATION OF C3¿TH1 AND IN THIS PATIENT, THE CONSTRUCT WAS SUBSEQUENTLY LENGTHENED TO TH5. 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. A COPY OF THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN ¿ SYNEX CAGE AND REFERS TO THREE (3) UNKNOWN PATIENTS HAD CONSTRUCT FAILURE. ONE PATIENT HAD EARLY DISLOCATION OF THE CAGE THAT WAS NOTED ON THE POSTOPERATIVE CT SCAN. IMPLANTATION OF THE CAGE WAS TECHNICALLY DIFFICULT BECAUSE OF SEVERE KYPHOSIS OF THE AFFECTED SEGMENT. THE PATIENT WAS RE-OPERATED SEVERAL DAYS LATER; REPOSITIONING OF THE CAGE WAS NOT PERFORMED BECAUSE OF A STABLE POSITION OF THE CAGE. THE OTHER TWO PATIENTS HAD CONSTRUCT FAILURES OCCURRED MORE THAN 3 YEARS AFTER THE INITIAL SURGERY, IN WHICH ONE PATIENT HAD PROGRESSIVE KYPHOSIS AFTER A TWO-LEVEL CORPECTOMY OF C5¿C6 WITH POSTERIOR FIXATION OF C3¿TH1 AND IN THIS PATIENT, THE CONSTRUCT WAS SUBSEQUENTLY LENGTHENED TO TH5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801780 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention