BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER 2 X-TAB 6X40MM TI

    MDR report key: 3040990 · Received April 8, 2013

    Report

    Report Number
    1526439-2013-15031
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 12, 2013
    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

    THE SCREW REMAINS IMPLANTED. THE AFFILIATE REPORTS THE DEVICE IS FROM ONE OF THREE POSSIBLE LOT CODES: TBCHW (DATE OF MFG 08/07/2012), T8770 (DATE OF MFG 11/16/2011), OR TBASD (DATE OF MFG 03/08/2012). REVIEWS OF THE DEVICE HISTORY RECORDS IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THE PRODUCTS THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCTS WERE RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. IN THE ABSENCE OF A PRODUCT SAMPLE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT POST OPERATIVE X-RAY AND CT SCAN REVEALED THE SCREW HAD LOOSENED. THE PROCEDURE WAS T8 - L2 PERFORMED ON (B)(6) 2013. THE DEVICE REMAINS IMPLANTED. AFFILIATE REPORTS THERE HAVE BEEN NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143374 VIPER 2 X-TAB 6X40MM TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention