BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSFERION

    MDR report key: 3890140 · Received June 16, 2014

    Report

    Report Number
    3007738819-2014-00003
    Event Type
    Other
    Date Received
    June 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE (REFERENCED IN THIS REPORT) WAS NOT RETURNED TO OLYMPUS TERUMO BIOMATERIALS CORP FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO IRREGULARITIES WERE NOTED. THIS FAILURE WOULD BE PREVENTED IF THE SURGEON HAD IMPLANTED THIS PRODUCT WHILE CAREFULLY CHECKING THE RECIPIENT SITE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IS AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING A SPINAL FUSION SURGERY, TWO PACKS OF THIS PRODUCT (GRANULE TYPE) WERE IMPLANTED IN THE 11TH AND 12TH THORACIC VERTEBRAE. AFTERWARDS, FROM THE POSTOPERATIVE EXAMINATION, IT BECAME CLEAR THAT THIS PRODUCT PROTRUDED FROM A PEDICLE INTO THE SPINAL CANAL. ABOUT TWO WEEKS AFTER THE SURGERY, WITH THE COMPLAINTS OF PAIN (NEURALGIA) AND NUMBNESS, THE PT UNDERWENT A REOPERATION, THE PROTRUSION OF THIS PRODUCT WAS REMOVED. THE PAIN (NEURALGIA) AND NUMBNESS SUBSIDED, AND THE PT MADE A RECOVERY. THIS PRODUCT PROTRUDED FROM THE PEDICLE THAT HAD BEEN BROKEN BY A SCREW WHEN THE ROD WAS TIGHTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353385 OSFERION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION M14108B335

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention