BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP PEEK INTERSPINOUS SPACER

    MDR report key: 4627407 · Received March 24, 2015

    Report

    Report Number
    1030489-2015-00632
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    May 21, 2012
    Report Date
    September 11, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    ADD'L INFO.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGERY WITH AN INTERSPINOUS SPACER AT L4/L5 AND WAS HOSPITALIZED FOR FIVE DAYS. ELEVEN DAYS POST-OP, BACKWARD MIGRATION OF THE IMPLANT WAS CONFIRMED ON POSTOPERATIVE X-RAY EXAMINATION. THE SPACER THAT WAS IMPLANTED IN THE ANTERIOR PART BETWEEN SPINOUS PROCESSES MIGRATED TO THE BOTTOM OF SUPRASPINAL LIGAMENT. NO SIGNIFICANT SYMPTOMATIC WORSENING WAS NOTED. THE EVENT SEVERITY WAS NON-SERIOUS. THE EVENT OUTCOME WAS REPORTED TO BE RESOLVING ONE YEAR POST-OP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, PATIENT UNDERWENT AN X-RAY EXAMINATION WHICH REVEALED MAINTENANCE OF THE INTERSPINOUS EXPANSION AND APPROPRIATE PLACEMENT OF IMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED FROM THE PATIENT¿S 1,2 YEARS POSTOPERATIVE CRF ON (B)(6) 2017. DURATION OF DISORDER: LESS THAN 6 TO 12 MONTHS PAIN PART: LOWER LIMB DATE OF HOSPITALIZATION: (B)(6) 2012 PATIENT UNDERWENT IMAGE INVESTIGATION WHICH REVEALED: [AT THE OPERATION] INTERSPINOUS ENLARGEMENT WAS MAINTAINED. PLACEMENT OF IMPLANT WAS APPROPRIATE. [SEVEN (7) DAYS AFTER THE OPERATION] (B)(6) 2012, IMAGE INVESTIGATION WAS PERFORMED BY X-RAY. INTERSPINOUS ENLARGEMENT WAS MAINTAINED. PLACEMENT OF IMPLANT WAS INAPPROPRIATE. [ONE (1) MONTH AFTER THE OPERATION] (B)(6) 2012, IMAGE INVESTIGATION WAS PERFORMED BY X-RAY. INTERSPINOUS ENLARGEMENT WAS MAINTAINED. PLACEMENT OF IMPLANT WAS INAPPROPRIATE. [SIX (6) MONTHS AFTER THE OPERATION] (B)(6) 2012, IMAGE INVESTIGATION WAS PERFORMED BY X-RAY. INTERSPINOUS ENLARGEMENT WAS NOT MAINTAINED. PLACEMENT OF IMPLANT WAS INAPPROPRIATE. [TWELVE (12) MONTHS AFTER THE OPERATION] (B)(6) 2013, IMAGE INVESTIGATION WAS PERFORMED BY X-RAY. INTERSPINOUS ENLARGEMENT WAS NOT MAINTAINED. PLACEMENT OF IMPLANT WAS INAPPROPRIATE. REGARDING THE IMAGE INVESTIGATION, THE DOCTOR COMMENTED THAT THE IMPLANT MALPOSITION WAS ASSOCIATED WITH SPINOUS FRACTURE. THE DATE OF THE EVENT ¿ DISPLACEMENT OF THE IMPLANT¿ WAS CORRECTED FROM (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195253 X-STOP PEEK INTERSPINOUS SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR