BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 6.0 X 50MM

    MDR report key: 11627771 · Received April 7, 2021

    Report

    Report Number
    1526439-2021-00645
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Report Date
    March 16, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034129211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) SHOWED THE X-TAB PORTION OF THE IMPLANT HAD BROKEN OFF FROM THE PROXIMAL END. NO OTHER ISSUES WERE IDENTIFIED. A DEVICE FAILURE WAS IDENTIFIED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE COMPLAINT ARE UNKNOWN. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : PRODUCT CODE: 186760050, LOT NUMBER: 171337. DEVICE HISTORY REVIEW: THE DHR OF PRODUCT CODE 186760050, LOT 171337, WAS REVIEWED AND NO NON-CONFORMANCE WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON NOVEMBER 29, 2017. THE DHR WAS ELECTRONICALLY REVIEWED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 THAT ON AN UNKNOWN DATE, TWO UNITS OF MIS CANNULATED X-TAB 6X50MM TI WERE RECEIVED AND IDENTIFIED THAT THE X-TAB ON BOTH DEVICES WERE CUT OFF. THERE IS NO PATIENT INVOLVEMENT. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 6.0 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525623 VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 6.0 X 50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH 186760050 171337 10705034129211

    Patients

    Seq Age Sex Outcome Treatment
    1