BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 2724751 · Received September 4, 2012

    Report

    Report Number
    2953769-2012-00126
    Event Type
    Injury
    Date Received
    September 4, 2012
    Report Date
    August 6, 2012
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: DAVID H. KIM ET AL. "ASSOCIATION BETWEEN DEGENERATIVE SPONDYLOLISTHESIS AND SPINOUS PROCESS FRACTURE AFTER INTERSPINOUS PROCESS SPACER SURGERY". THE SPINE JOURNAL 12 (2012); 466-472. OTHER: FRACTURE OF TREATED INTERSPINOUS PROCESS. DATE OF EVENT IS UNKNOWN. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PROSPECTIVE (B)(6) STUDY THAT 38 PATIENTS UNDERWENT IPS (INTERSPINOUS PROCESS SPACER) SURGERY FOR LSS (LUMBAR SPINAL STENOSIS) WITH NEUROGENIC CLAUDICATION WITH A 1-YEAR FOLLOW-UP TIME PERIOD. IMPLANTS INCLUDED DEVICES COMPRISED OF TITANIUM OR PEEK FROM MULTIPLE MANUFACTURERS. IT WAS REPORTED THAT A SPINOUS PROCESS FRACTURE OF L4 WAS IDENTIFIED BY CT IN A (B)(6) MALE PATIENT 1 MONTH AFTER PLACEMENT OF AN INTERSPINOUS SPACER AT L4-L5. GRADE 1 DEGENERATIVE SPONDYLOLISTHESIS WAS ALSO OBSERVED AT THE SURGICAL LEVEL. NO FRACTURES WERE APPARENT ON THE LATERAL RADIOGRAPH TAKEN THE SAME DAY. REPEAT CT SCAN WAS PERFORMED 1 YEAR AFTER SURGERY AND REVEALED SPONTANEOUS HEALING OF THE FRACTURE. NO FURTHER PATIENT INFORMATION OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP IPD SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MDT KYPHON SUNNYVALE MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Other