BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER MIS CANNULATED X-TAB SCREW

    MDR report key: 4113742 · Received September 24, 2014

    Report

    Report Number
    1526439-2014-11922
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    July 31, 2013
    Report Date
    August 30, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK041801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. NOT RETURNED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT T8-L3 INSTRUMENTATION WAS PERFORMED USING VIPER X-TAB SCREWS IN (B)(6) 2013 FOR THE PATIENT WITH INFECTIOUS SPONDYLITIS AND OSTEOPOROSIS. SEVENTEEN DAYS AFTER THE SURGERY, FOLLOW UP X-RAYS FOUND THE X-TAB SCREWS WERE SLIGHTLY BACKED OUT. TWELVE X-TAB SCREWS WERE REMOVED ON (B)(6) 2013. ACCORDING TO THE SURGEON, THE PATIENT HAD A POOR QUALITY BONE AND IT MAY BE A POSSIBLE CAUSE OF THE BACK-OUT. OF THE TWELVE SCREWS THAT WERE EXPLANTED, THE EXACT NUMBER OF BACKED OUT SCREWS IS UNKNOWN. AS SUCH, TWELVE MFG. MEDWATCH REPORTS ARE BEING FILED, ONE FOR EACH SCREW THAT MAY HAVE BEEN BACKED OUT POST-OPERATIVELY, TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595469 VIPER MIS CANNULATED X-TAB SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE TBEGR

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention