BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVENTIONAL SPINE

    MDR report key: 7316144 · Received March 6, 2018

    Report

    Report Number
    1526439-2018-50204
    Event Type
    Injury
    Date Received
    March 6, 2018
    Date of Event
    January 1, 2018
    Report Date
    February 14, 2018
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    UDI-DI
    00811954013219
    PMA / PMN Number
    K082795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED, REVISION SURGERY FOR THE INTERVENTIONAL SPINE FACET SCREW (PRODUCT CODE/DESCRIPTION BELOW) OCCURRED ON FRIDAY (B)(6) 2018. REVISION SURGERY WENT WELL WITH A DEPUY SPINE REVISION SET. NO FURTHER INFORMATION KNOWN. PART NUMBER FOR ISPINE SCREW 9024-01 (UNRECOGNIZED PART IN UNITY) REASON FOR REVISION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162469 INTERVENTIONAL SPINE SYSTEM, FACET SCREW SPINAL DEVICE MRW INTERVENTIONAL SPINE, INC. 00811954013219

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention