BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION FO DJD

    MDR report key: 5183051 · Received October 28, 2015

    Report

    Report Number
    2520274-2015-16844
    Event Type
    Injury
    Date Received
    October 28, 2015
    Report Date
    October 20, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. PERERA, A; QURESHI, A; BRECKNELL, J. (2014) MONO-SEGMENT FIXATION OF THORACOLUMBAR BURST FRACTURES. BRITISH JOURNAL OF NEUROSURGERY, EARLY ONLINE: 1-4. THIS REPORT IS FOR AN UNKNOWN PEDICLE SCREW (UNKNOWN QUANTITY/UNKNOWN LOT). (B)(4) MALPOSITION. THE INVESTIGATION COULD NOT BE COMPLETED; 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 SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: PERERA, A; QURESHI, A; BRECKNELL, J. (2014) MONO-SEGMENT FIXATION OF THORACOLUMBAR BURST FRACTURES. BRITISH JOURNAL OF NEUROSURGERY, EARLY ONLINE: 1-4. A RETROSPECTIVE ANALYSIS WAS PERFORMED OF CLINICAL NOTES AND RADIOLOGY FOR 22 CONSECUTIVE PATIENTS WHO UNDERWENT SURGICAL FIXATION OF THORACOLUMBAR BURST FRACTURE (TLBF) BETWEEN 2007 AND 2012 IN A SINGLE (B)(6) INSTITUTION. CONSTRUCTS EITHER FIXED THE VERTEBRA ABOVE THE FRACTURE TO THE VERTEBRA BELOW (SHORT SEGMENT FIXATION (SSF) OR FIXED THE VERTEBRA ABOVE TO THE RELATIVELY WELL-PRESERVED PEDICLES AND INFEROLATERAL PORTIONS OF THE BODIES OF THE FRACTURED VERTEBRA (MONO-SEGMENT FIXATION (MSF). ELEVEN PATIENTS IN EACH GROUP WERE INCLUDED. BOTH GROUPS UNDERWENT PEDICLE SCREW FIXATION (SYNTHES, USS FRACTURE SET) FROM A POSTERIOR MIDLINE APPROACH. THERE WERE NO REPORTS OF POSTOPERATIVE WOUND INFECTIONS IN ANY OF THE PATIENTS AND NO DECLINE IN NEUROLOGICAL FUNCTION. THERE WAS ONE REPORT OF METAL WORK REMOVAL IN THE MSF GROUP 6 MONTHS POSTOPERATIVELY DUE TO A MALPOSITIONED SCREW IN THE LEFT PEDICLE. MSF DISPLAYED A SHORTER OPERATIVE TIME THAN SSF, ON AVERAGE 58 MINUTES QUICKER). IN THIS PAPER WE HAVE DEMONSTRATED A SIGNIFICANTLY SHORTER OPERATIVE TIME FOR MSF OVER SSF IN THE TREATMENT OF TLBFS. STRONG TRENDS TOWARDS EARLIER MOBILIZATION AND LOWER OPIATE USE FAILED TO REACH SIGNIFICANCE IN THIS SMALL RETROSPECTIVE SERIES. THESE RESULTS GO SOME WAY TOWARDS ESTABLISHING THE EXISTENCE OF REAL BENEFITS FOR MSF OVER SSF. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PEDICLE SCREW FIXATION IN THE MSF GROUP AND REFERS TO AN UNKNOWN PATIENT WHO EXPERIENCED SERIOUS INJURY METAL WORK REMOVAL AND SCREW MALPOSITION IN THE LEFT PEDICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713059 ORTHOSIS, SPINAL PEDICLE FIXATION FO DJD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention