BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER 2 X-TAB 6X45MM TI

    MDR report key: 2882199 · Received December 20, 2012

    Report

    Report Number
    1526439-2012-00313
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 24, 2012
    Report Date
    February 5, 2013
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    NKB
    PMA / PMN Number
    K041801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREWS WERE DISCARDED AND THE LOT NUMBERS ARE UNKNOWN. WITHOUT LOT NUMBERS, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED AND WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. COMPLAINT DATA IS REVIEWED MONTHLY VIA THE SPINE MONTHLY COMPLAINT REVIEW MEETING TO IDENTIFY AND INITIATION ACTION AGAINST ANY EMERGING TRENDS. THE MEETING INCLUDES CROSS FUNCTIONAL REPRESENTATION FROM RD, QUALITY ENGINEERING, CLINICAL RESEARCH, AND COMPLAINT HANDLING TO ENSURE A ROBUST REVIEW. NO TRENDS WERE NOTED. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED. DISCARDED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICES FOUND NO VISUAL ANOMALIES. FUNCTIONAL TEST DETERMINED THAT THE RETURNED DEVICES ARE FUNCTIONING AS INTENDED. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO WHY THE DIRECTION OF THE SCREWS ON THE PATIENTS LEFT SIDE WAS NOT APPROPRIATE. COMPLAINT DATA IS REVIEWED MONTHLY BY CROSS FUNCTIONAL GROUPS WITHIN THE COMPANY TO ENSURE A ROBUST REVIEW. COMPLAINT DATA REVIEW FOUND NO EMERGING TRENDS. AT THIS TIME THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT L5-S1 INSTRUMENTATION WAS PERFORMED WITH THE VIPER SPINAL SYSTEM. AFTER SURGERY, IT WAS FOUND THAT THE DIRECTION OF TWO SCREWS IMPLANTED IN THE LEFT SIDE OF THE CONSTRUCT WERE NOT APPROPRIATE. REVISION SURGERY WAS PERFORMED AND THE TWO SCREWS WERE REMOVED. BOTH SCREWS WERE CATALOG# 186760045, LOT CODES UNKNOWN. THE DEVICES WERE DISCARDED AND ARE NOT AVAILABLE FOR EVALUATION. NOTE: THE AFFILIATE WAS ASKED TO PROVIDE CLARIFICATION. HOWEVER, THE REQUESTED INFORMATION WAS NOT PROVIDED AS OF THE DATE OF THE FILING OF THE MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER 2 X-TAB 6X45MM TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY RAYNHAM TBCHP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VIPER2 ROD, 186788035| VIPER SET SCREWS, 186715000 X 2