BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 TI CORT FIX 6X35MM

    MDR report key: 7691163 · Received July 16, 2018

    Report

    Report Number
    1526439-2018-50688
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    June 1, 2018
    Report Date
    June 4, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWQ
    UDI-DI
    10705034351810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE SCREW REVEALED THAT THE INNER CAP (SADDLE) IS LOOSENED TO A CERTAIN DEGREE FROM ITS INTENDED LOCATION. ALSO, THE SCREW HAS SIGNIFICANT INDENTATION MARKS AND WORN THREADS FROM THE OPERATIVE USAGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. THE ROOT CAUSE CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE MAY BE EXCESSIVE FORCE INADVERTENTLY PLACED ON THE DRIVE FEATURE OF THE SCREW DURING TIGHTENING, POTENTIALLY AT A SIGNIFICANT ANGLE, RESULTING IN THE SADDLE FALLING APART DURING USE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    ON (B)(6) 2018, THE SURGERY FOR THORACIC POSTERIOR FIXATION WAS PERFORMED FOR BY USING THE EXPEDIUM PLUS SPINE SYSTEM. DURING THE SURGERY, THE SURGEON HAD AN UNCOMFORTABLE FEELING WITH THE SCREW (186731635, LOT#: 190598) WHEN HE WAS TRYING TO ATTACH IT TO A SCREW DRIVER (PART#: UNK). THEN HE TRIED TO DETACH IT FROM THE SCREW DRIVER, BUT IT COULD NOT BE DETACHED AT ALL. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A LESS-THAN-30-MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533274 5.5 TI CORT FIX 6X35MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDOS INTERNATIONAL SàRL CH 186731635 190598 10705034351810

    Patients

    Seq Age Sex Outcome Treatment
    1