BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)

    MDR report key: 6092249 · Received November 10, 2016

    Report

    Report Number
    3005180920-2016-00576
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 11, 2016
    Report Date
    December 9, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWQ
    PMA / PMN Number
    K140361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: A FIXATION SCREW BACKED OUT OF THE CERVICAL PLATE FEW DAYS AFTER OPERATION. A CLINICAL CAUSE FOR THIS EVENT IS UNLIKELY, PARTICULARLY AT SUCH SHORT FOLLOW-UP. NO INFORMATION IS AVAILABLE TO CONFIRM THAT THE TORQUE LIMITING SCREW DRIVER HAS BEEN USED PROPERLY DURING FINAL TIGHTENING OF THE SCREW AT PRIMARY SURGERY. THE CLINICAL INVESTIGATION CANNOT EXPLAIN THE REASONS FOR THIS SITUATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 10 NOVEMBER 2016 AND INCLUDES: REFERENCE AND LOTS OF THE DEVICES INVOLVED IN THE COMPLAINT. ADDITIONAL INFORMATION RECEIVED ON 10 NOVEMBER 2016 AND INCLUDES: THE CRANIAL, TOP LEFT, SCREW IS THE ONE THAT BACKED OUT OF THE CERVICAL PLATE. ITS LOT NUMBER IS UNKNOWN. BATCH REVIEWS PERFORMED ON 05 DECEMBER 2016. LOT 1520503: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 FEBRUARY 2016. EXPIRATION DATE: 2021-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT; CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4.5X18MM (1X), CODE 03.70.396, LOT. 141349 (K140361), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 OCTOBER 2014. EXPIRATION DATE: 2019-08-31. O ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE ONLY ITEM SOLD OF THE SAME LOT; CERVICAL PLATE FIXED SELF-DRILLING SCREW DIAM. 4X18MM (2X), CODE 03.70.159, LOT. 1520493 (K140361), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 MARCH 2016. EXPIRATION DATE: 2021-02-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT; CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4.5X18MM (1X), CODE 03.70.084, LOT. 1520556 (K140361), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JULY 2016. EXPIRATION DATE: 2021-05-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE SURGEON BELIEVES A CERVICAL SCREW BACKED OUT OF THE CERVICAL PLATE. X-RAYS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743168 CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X) CERVICAL SCREW KWQ MEDACTA INTERNATIONAL SA 1520503

    Patients

    Seq Age Sex Outcome Treatment
    1 Other