BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT, FIXATION DEVICE, SPINAL

    MDR report key: 4852459 · Received June 18, 2015

    Report

    Report Number
    2520274-2015-14452
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    June 10, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 1 UNKNOWN ARCH SYSTEM/UNKNOWN PART AND LOT NUMBERS. REPORTER: (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO PART OR LOT NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: ZHOU, D., & ET AL. APPLICATION OF LAMINA REPLANTATION WITH ARCH PLATE FIXATION IN THORACIC AND LUMBAR INTRASPINAL TUMORS. EXPERIMENTAL AND THERAPEUTIC MEDICINE 6: 596-600. THE GOAL OF THIS STUDY WAS TO INVESTIGATE THE CLINICAL EFFECTS OF LAMINA REPLANTATION WITH ARCH (SYNTHES) PLATE FIXATION ON PATIENTS WITH THORACIC AND LUMBAR INTRASPINAL TUMORS, FOLLOWING LAMINECTOMY. THIRTEEN PATIENTS WITH THORACIC AND LUMBAR INTRASPINAL TUMORS UNDERWENT TOTAL LAMINA REPLANTATION WITH ARCH PLATE FIXATION AND REPAIR OF THE SUPRASPINOUS LIGAMENTS, FOLLOWING LAMINECTOMY AND TUMOR ENUCLEATION. THERE WERE 8 FEMALES AND 5 MALES WITH AN AGE RANGE OF 28 TO 52 YEARS. TO INVESTIGATE THE CLINICAL EFFECT OF LAMINA REPLANTATION WITH ARCH PLATE FIXATION, PRE AND POSTOPERATIVE VISUAL ANALOG SCALE (VAS), AND OSWESTRY DISABILITY INDEX (ODI) SCORES WERE DETERMINED, AND PRE AND POSTOPERATIVE X-RAY AND MAGNETIC RESONANCE IMAGING (MRI) EXAMINATIONS WERE CONDUCTED. COMPUTED TOMOGRAPHY (CT) EXAMINATIONS WERE ALSO INCLUDED IN THE FOLLOW UP. THE VAS AND ODI RESULTS 2 WEEKS FOLLOWING SURGERY AND AT THE FINAL FOLLOW UP EXAMINATION DEMONSTRATED A SIGNIFICANT IMPROVEMENT COMPARED WITH THE CORRESPONDING PREOPERATIVE RESULTS. THE X-RAY EXAMINATION RESULTS INDICATED A SATISFACTORY INTERNAL FIXATION LOCATION, WITHOUT ANY CHARACTERISTICS OF A FRACTURE, LUMBAR SCOLIOSIS, KYPHOSIS OR INSTABILITY. FOLLOWING THE SURGERY, THE CT AND MRI EXAMINATION RESULTS DEMONSTRATED THAT HEALING OF THE LAMINA BONE AND REPAIR OF THE SUPRASPINOUS LIGAMENT HAD OCCURRED WITHOUT TUMOR RECURRENCE OR SPINAL EPIDURAL SCAR RECOMPRESSION. ONE PATIENT DEVELOPED POSTOPERATIVE CEREBRAL SPINAL FLUID LEAKAGE AND SPONTANEOUSLY RECOVERED FOLLOWING CONSERVATIVE TREATMENT. TWO OF THE 13 CASES WERE LOST TO FOLLOW-UP. THE RESULTS INDICATED THAT IN PATIENTS WITH THORACIC AND LUMBAR INTRASPINAL TUMORS, LAMINA REPLANTATION WITH ARCH PLATE FIXATION FOLLOWING TOTAL LAMINECTOMY IS EFFECTIVE AND PROVIDES THORACOLUMBAR STABILITY. THIS REPORT IS FOR AN UNKNOWN ARCH SYSTEM CONCERNING ONE PATIENT WITH A CEREBRAL SPINAL FLUID LEAK. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398449 IMPLANT, FIXATION DEVICE, SPINAL JDN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention