BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON-FIBER COMPOSITE, LORDOTIC, 5°, 9X10X23MM

    MDR report key: 4844499 · Received June 15, 2015

    Report

    Report Number
    1526439-2015-10550
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Report Date
    May 19, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PK052746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. SAMPLE NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    CASE DATE: (B)(6) 2015. POST OP CASE FILMS INDICATE APPROPRIATE PLACEMENT OF CONCORDE BULLET IMPLANT. POST OPERATIVE FILM IS INCLUDED IN REPORT SUBMISSION. PATIENT REPORTS TO ER, FILMS INDICATE CAGE HAS RETROPULSED INTO THE CANAL. SURGEON NOTIFIED REP OF REPORTABLE EVENT ON 5/19/2015. FILMS SHOWING MIGRATED CAGE INCLUDED IN REPORT SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387555 CARBON-FIBER COMPOSITE, LORDOTIC, 5°, 9X10X23MM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other