BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW ROD COCR 5.5X200

    MDR report key: 8802420 · Received July 18, 2019

    Report

    Report Number
    3005180920-2019-00577
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 18, 2019
    Report Date
    July 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030835421
    PMA / PMN Number
    K121115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 JUN 2019: LOT 144214: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2016. EXPIRATION DATE: 17-APR-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 OTHER SIMILAR EVENT REPORTED, IN TOTAL 4 ITEMS INVOLVED (2 IN THIS COMPLAINT). ADDITIONAL IMPLANT INVOLVED IN THIS EVENT: PEDICLE SCREW 03.50.432 ROD COCR 5.5X300 (K121115) LOT. 144215. BATCH REVIEW PERFORMED ON 28 JUN 2019: LOT 144215: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2015. EXPIRATION DATE: 03-MAY-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 2 OTHER SIMILAR EVENTS REPORTED (4 ITEMS INVOLVED). VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: IN ALL THE THREE ROD PACKAGES THE INNER PEEL POUCH IS BROKEN. A POTENTIAL ROOT CAUSE OF THE EVENT COULD BE A SHOCK DURING THE DELIVERY OF THE IMPLANT.

    Description of Event or Problem · 1

    ONCE THE NURSE OPENED THE BOX OF THE IMPLANT (2 OF 200 MM RODS AND 1 OF 300 MM ROD), THE PACKAGING OF THE ROD (DOUBLE "PAPER") WAS BROKEN. ANOTHER ROD (5.5X300) WAS OPENED AND USED BUT, IN ORDER TO HAVE THE DESIRED DIMENSION, IT WAS CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594890 PEDICLE SCREW ROD COCR 5.5X200 PEDICLE SCREW ROD KWP MEDACTA INTERNATIONAL SA 144214 07630030835421

    Patients

    Seq Age Sex Outcome Treatment
    1 Other