BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM

    MDR report key: 6964817 · Received October 20, 2017

    Report

    Report Number
    1526439-2017-10876
    Event Type
    Injury
    Date Received
    October 20, 2017
    Report Date
    October 3, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS GENERATED FROM LITERATURE REVIEW CONDUCTED IN POST MARKET SURVEILLANCE (PMS) FOR HEALTH AUTHORITY REPORTING PURPOSES. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE PMS IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: PRELIMINARY RESULTS OF THE EFFECT OF PROPHYLACTIC VERTEBROPLASTY ON THE INCIDENCE OF PROXIMAL JUNCTIONAL COMPLICATIONS AFTER POSTERIOR SPINAL FUSION TO THE LOW THORACIC SPINE. SPINE DEFORMITY, 1(2), 132-138. MARTIN, C. T., SKOLASKY, R. L., MOHAMED, A. S., & KEBAISH, K. M. (2013). RECEIVED 31 JULY 2012; REVISED 7 JANUARY 2013; ACCEPTED 9 JANUARY 2013. N=1 PATIENT WITH SEVERE OSTEOPOROSIS FELL 7 WEEKS AFTER SURGERY, COMPRESSION FRACTURE. N=2 PATIENTS HAD PARTIAL REMOVAL OF INSTRUMENTATION FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745245 EXPEDIUM UNKNOWN NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other