BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    MDR report key: 5050533 · Received September 2, 2015

    Report

    Report Number
    2520274-2015-15589
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    June 10, 2009
    Report Date
    August 26, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BECK M., MITTLMEIER T., GIERER P., HARMS C., GRADL G. (2009). BENEFIT AND ACCURACY OF INTRAOPERATIVE 3D-IMAGING AFTER PEDICLE SCREW PLACEMENT: A PROSPECTIVE STUDY IN STABILIZING THORACOLUMBAR FRACTURES. EUR SPINE J. 18: 1469-1477. GERMANY. THIS REPORT IS FOR TWO UNKNOWN USS SCREWS/ UNKNOWN LOT NUMBER. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE AS 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: BECK M., MITTLMEIER T., GIERER P., HARMS C., GRADL G. (2009). BENEFIT AND ACCURACY OF INTRAOPERATIVE 3D-IMAGING AFTER PEDICLE SCREW PLACEMENT: A PROSPECTIVE STUDY IN STABILIZING THORACOLUMBAR FRACTURES. EUR SPINE J. 18: 1469-1477. THE PURPOSE OF THIS STUDY WAS TO CLARIFY THE DIAGNOSTIC VALUE OF INTRAOPERATIVE 3D SCANS AFTER PEDICLE SCREW IMPLANTATION IN THORACOLUMBAR SPINE SURGERY. INTRAOPERATIVE 3D SCANS WERE PROSPECTIVELY CARRIED OUT FROM JUNE 2006 TO OCTOBER 20087 ON 95 PATIENTS (55 MALE, 40 FEMALE) WITH FRACTURES OF THE THORACOLUMBAR SPINE THAT HAVE BEEN TREATED WITH INTERNAL FIXATION. THE PATIENTS AGED BETWEEN 11 AND 82 YEARS, WITH A MEAN AGE OF 54). FOR FIXATION, SYNTHES UNIVERSAL SPINE SYSTEMS SCREW WITH A THICKNESS OF 4.0 -7.2 MM WERE USED. SCREWS POSITIONS WERE CATEGORIZED INTRAOPERATIVELY, SCREWS IN RELEVANT MALPOSITION WERE REPOSITIONED IMMEDIATELY. 414 PEDICLES WITH ENCLOSED SCREWS WERE RECORDED AND EVALUATED BY THE 3D SCANS. THIS REPORT REFERS TO TWO OF THE 95 PATIENTS THAT HAD TO HAVE FALSE POSITIONS OF THE SCREWS REVISED SECONDARILY FOLLOWING EVALUATION OF THE COMPUTED TOMOGRAPHIES. THE SECONDARY POSTOPERATIVE REVISION RATE OF THE PATIENTS AMOUNTS TO 2.1%. IN ONE CASE, A TYPE IIIA MALPOSITIONED SCREW (T7) COMPROMISED THE STABILITY OF THE FIXATEUR- THERE WAS AN INTRAOPERATIVE MISINTERPRETATION OF THE 3D SCAN CAUSED BY A LACK OF EXPERIENCE WITH THE OPERATING CONSOLE OF THE IMAGE INTENSIFIER IN THE CONTEXT OF THE "LEARNING CURVE." IN THE OTHER CASE A TYPE IIIB MALPOSITIONED SCREW (T6) NARROWED THE DIAMETER OF THE SPINAL CANAL. TO PREVENT SECONDARY LESIONS OF THE MYELON AND THE ROOD IT WAS DECIDED TO CORRECT THE DEFICIT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR TWO UNKNOWN UNIVERSAL SPINE SYSTEMS (USS) SCREWS WITH A POSSIBLE THICKNESS OF 4.0 -7.2MM, UNKNOWN PART #/UNKNOWN LOT #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580281 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention