BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENT DISPENSER

    MDR report key: 4896361 · Received July 7, 2015

    Report

    Report Number
    2520274-2015-14540
    Event Type
    Injury
    Date Received
    July 7, 2015
    Report Date
    June 9, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    OAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MOUSSAZADEH, N., ET AL. (2015) SHORT-SEGMENT PERCUTANEOUS PEDICLE SCREW FIXATION WITH CEMENT AUGMENTATION FOR TUMOR-INDUCED SPINAL INSTABILITY. THE SPINE JOURNAL. THIS REPORT IS FOR AN UNKNOWN NUMBER OF VERTECEM SYSTEM/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE 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 ARTICLE: MOUSSAZADEH, N., ET AL. (2015) SHORT-SEGMENT PERCUTANEOUS PEDICLE SCREW FIXATION WITH CEMENT AUGMENTATION FOR TUMOR-INDUCED SPINAL INSTABILITY. THE SPINE JOURNAL. (USA). THE OBJECTIVE OF THE STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF CEMENT-AUGMENTED SHORT-SEGMENT PERCUTANEOUS POSTEROLATERAL INSTRUMENTATION FOR TUMOR-ASSOCIATED VERTEBRAL COMPRESSION (VCF) WITH PEDICLE AND JOINT INVOLVEMENT. FORTY-FOUR PATIENTS, AGED 29-83 (MEDIAN-(B)(6) YEARS) WITH TUMOR-RELATED PATHOLOGIC COMPRESSION OR BURST FRACTURES WERE ENROLLED IN THE STUDY. THE PATIENTS UNDERWENT PERCUTANEOUS PEDICLE SCREW INSTRUMENTATION BETWEEN 2011 AND 2014. A RETROSPECTIVE ANALYSIS OF PROSPECTIVELY-COLLECTED DATA, INCLUDING VISUAL ANALOG PAIN RESPONSE SCORE (VAS) AND PROCEDURAL COMPLICATIONS, WAS PERFORMED. THE VERTECEM VERTEBROPLASTY SYSTEM JAMSHIDI NEEDLE (SYNTHES, INC., WEST CHESTER, PA) WAS USED FOR FIXATION OF THE FRACTURES DURING THE VERTEBROPLASTY AND KYPHOPLASTY PROCEDURES. PATIENTS WITH A MEDIAN COMPOSITE SPINAL INSTABILITY NEOPLASTIC SCORE OF 10 (RANGE=8-15) WERE TREATED WITH CONSTRUCTS SPANNING 1-4 DISK SPACES (MEDIAN 2 SPACES, CONSTITUTING 84% OF ALL CASES). THE PROPORTION OF PATIENTS SUFFERING SEVERE PAIN DECREASED FROM 86% (38 PATIENTS) PREOPERATIVELY TO 0% AT THE LAST FOLLOW-UP VISIT; 66% (29 PATIENTS) REPORTED COMPLETE PAIN RESOLUTION POSTOPERATIVELY. AT THE LAST FOLLOW-UP VISIT, 30% (13 PATIENTS) NOTED MILD PAIN, AND 5% (2 PATIENTS) HAD CONTINUED PAIN. ONE PATIENT WITH PREVIOUS RADIOTHERAPY AND A HISTORY OF BONE MARROW TRANSPLANT FOR TREATMENT OF MULTIPLE MYELOMA HAD SEPSIS WITH DISTANT NECROTIZING FASCIITIS AND (B)(6) MONTHS POSTOPERATIVELY AND SUBSEQUENTLY DEVELOPED A PSOAS ABSCESS IN THE AREA OF THE HARDWARE REQUIRING DEBRIDEMENT. ONE PATIENT HAD AN ADJACENT-LEVEL FRACTURE AND REQUIRED A REPEAT KYPHOPLASTY. THIS IS REPORT 1 OF 1 FOR COM-(B)(4). THIS REPORT IS FOR AN UNKNOWN NUMBER OF VERTECEM SYSTEM, LOT NUMBER UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439318 CEMENT DISPENSER OAR SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention