BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSIS, PEDICLE, SPINAL FIXATION

    MDR report key: 5104432 · Received September 25, 2015

    Report

    Report Number
    2520274-2015-16152
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    August 25, 2004
    Report Date
    September 9, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN USS SCREW; UNKNOWN PART NUMBER/UNKNOWN LOT NUMBER. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: F܃HTMEIER, B., & ET AL (2004). THE MINIMALLY INVASIVE STABILIZATION OF THE DORSAL PELVIC RING WITH THE TRANSILIACAL INTERNAL FIXATOR (TIFI) - SURGICAL TECHNIQUE AND FIRST CLINICAL FINDINGS. UNFALLCHIRURG,12, 1142-1151. IN A PROSPECTIVE STUDY 31 PATIENTS WITH VERTICAL SHEAR INJURIES OF THE PELVIS WERE TREATED WITH THE TRANSILIACAL FIXATOR INTERNAL (TIFI). IN THIS STUDY, 7.0 MM PEDICLE SCREWS OF THE UNIVERSAL SPINE SYSTEM (USS) WERE INSERTED 1-2 CM ON THE CRANIAL SIDE OF THE POSTERIOR SUPERIOR ILIAC SPINE AND PARALLEL TO THE SUPERIOR GLUTEAL LINE. THE CONNECTING BAR WAS INSERTED SUBFASCIALLY AND FIXED WITH THE LOCKING HEAD PEDICLE SCREWS TO FORM A FIXED-ANGLE CONSTRUCTION. THERE WERE TWO WOUND INFECTIONS AND ONE LOOSENING OF A PEDICLE SCREW. NONE OF THE SCREWS WERE INCORRECTLY POSITIONED AND NO NEUROVASCULAR LESIONS WERE CAUSED BY THE IMPLANT. TWO YEARS POSTOPERATIVELY 50% OF THE PATIENTS HAD GOOD AND EXCELLENT RESULTS FOR TYPE C PELVIC RING INJURIES. THIS REPORT IS FOR AN UNKNOWN USS SCREW, UNKNOWN PART AND UNKNOWN LOT NUMBERS. THIS COMPLAINT INVOLVES ONE SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636713 ORTHOSIS, PEDICLE, SPINAL FIXATION MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1