BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 5145111 · Received October 13, 2015

    Report

    Report Number
    2027754-2015-00012
    Event Type
    Malfunction
    Date Received
    October 13, 2015
    Date of Event
    July 7, 2015
    Report Date
    January 3, 2018
    Manufacturer
    OSTEOMED
    Product Code
    MQN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THIS COMPLAINT IS RELATED TO IMPROPER SURGICAL TECHNIQUE. THE CUSTOMER RETURNED THE DEVICE COMPONENTS USED IN THE CASE. BASED UPON THE COMPONENTS RETURNED, THE SURGEON PERFORMED A LEFORT I DISTRACTION. A REVIEW OF THE SPECTRUM MID-FACE DISTRACTION SYSTEM SURGICAL TECHNIQUE GUIDE (030-1389) SHOWED THAT DETAILED INSTRUCTIONS ARE PROVIDED CONCERNING PROPER ASSEMBLY OF THE DISTRACTION DEVICES. AN ENGINEERING EVALUATION OF THE DEVICES AND X-RAYS DETERMINED THAT THE DISTRACTION CAPS WERE NOT USED. PER THE SURGICAL TECHNIQUE GUIDE, FOLLOWING THE ADJUSTMENT OF THE POSITION OF THE HORIZONTAL DISTRACTION ROD, SMALL CAPS SHOULD BE THREADED ONTO THE POSTERIOR ENDS OF THE HORIZONTAL DISTRACTION RODS TO PREVENT THE DEVICE FROM OVER DISTRACTING. A REVIEW OF THE SHIPMENT LIST SHOWED THAT THE CAPS (217-0067) WERE PROVIDED. HOWEVER, THEY WERE NOT USED. A REVIEW OF COMPLAINTS DID NOT IDENTIFY ANY COMPLAINTS FOR THIS DEVICE. A REVIEW OF NCRS DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THIS DEVICE. QA NOTE: DURING AN AUDIT OF MDR SUBMISSIONS, WE IDENTIFIED THAT THERE WAS AN ERROR ON THE FOLLOW-UP REPORT THAT PREVENTED UPLOAD TO MAUDE. THEREFORE, THIS REPORT IS BEING RE-SUBMITTED. DATE OF ORIGINAL UPDATE REPORT: 11/20/2015.

    Description of Event or Problem · 1

    ON (B)(6) 2015 OSTEOMED RECEIVED NOTIFICATION FROM (B)(6) CONCERNING OUR SPECTRUM MID-FACE DISTRACTION SYSTEM. ACCORDING TO THE COMPLAINT, THERE WAS AN EXCLUSION OF THE END OF THE ACTIVATION ROD G AT THE END OF ACTIVATION, COMPROMISING THE END OF TREATMENT. NEITHER THE EXACT PART NUMBER OF THE DEVICE, NOR THE LOT NUMBER HAS NOT BEEN PROVIDED. WE ARE AWAITING ADDITIONAL INFORMATION CONCERNING THE DETAILS OF THIS EVENT, AND THE RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675408 SPECTRUM LEFORTE I MQN OSTEOMED

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention