BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM OR MOSS MIAMI SCREW

    MDR report key: 4122092 · Received September 26, 2014

    Report

    Report Number
    1526439-2014-11931
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 18, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW AND COMPLAINT TREND ANALYSIS COULD NOT BE CONDUCTED AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. AN EVENT DESCRIPTION SEARCH ON POST MARKET SURVEILLANCE LITERATURE ASSOCIATED WITH REVISION SURGERY FOR INADEQUATE RESTORATION AND STRESS FRACTURE WAS PERFORMED INDICATED THAT THERE WERE NO REPORTED COMPLAINTS OTHER THAN THIS ONE FOR ISSUES OF THIS NATURE. THE ROOT CAUSE UNKNOWN. NO PRODUCT FAILURES HAVE BEEN IDENTIFIED. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS NECESSARY AT THIS TIME AS THERE WERE NO PRODUCT FAILURES INDICATED AND NO SYSTEMATIC TREND HAS BEEN IDENTIFIED. THEREFORE, THIS COMPLAINT FILE WILL CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NOT RETURNED.

    Description of Event or Problem · 1

    MEDICAL SAFETY REPORTED COMPLAINTS FROM LITERATURE THAT WAS REVIEWED AS PART OF POST MARKET SURVEILLANCE REPORTING. LITERATURE ARTICLE 10: PRELIMINARY RESULTS OF THE EFFECT OF PROPHYLACTIC VERTEBROPLASTY ON THE INCIDENCE OF PROXIMAL JUNCTIONAL COMPLICATIONS AFTER POSTERIOR SPINAL FUSION TO THE LOW THORACIC SPINE (MARTIN, C.) PUBLICATION DATE JAN 2013. CLINICAL FINDINGS DETERMINED BY MEDICAL SAFETY AND COMPLAINT MANAGEMENT: N=2 REVISION SURGERY. YES FOR INADEQUATE RESTORATION AND STRESS FRACTURE THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE TWO EVENTS INVOLVING INADEQUATE RESTORATION AND STRESS FRACTURE: 1526439-2014-11931. 1526439-2014-11932.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600763 EXPEDIUM OR MOSS MIAMI SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention