BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLIVIOPORE SIZ 10

    MDR report key: 3178004 · Received June 19, 2013

    Report

    Report Number
    8030965-2013-02723
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    June 16, 2011
    Report Date
    July 18, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. BASED ON THE CONDUCTED EXAMINATIONS, NO MATERIAL DEFECTS, NOR PRODUCTION DEFECTS, OR IMPERMISSIBLE CONTAMINATIONS COULD BE DETERMINED. THE IMPLANT CORRESPONDS TO THE INTERNAL GUIDELINES. THE CAUSE OF THE DAMAGE IS AN OVERLOAD FRACTURE BY EXCESSIVE STRESS.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAGE HAD BROKEN OFF. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PLIVIOPORE CAGES BROKE DURING THE IMPLANTATION UNDER ROTATION WITHIN THE INTER-VERTEBRAL DISC SPACE. ONE OF THE CAGES (LEFT SIDE) COULD COMPLETELY BE REMOVED. THE OTHER CAGE (RIGHT SIDE) COULD PARTIALLY BE REMOVED, BUT THE OTHER PART OF RIGHT SIDE OF THE CAGE WAS STUCK AND LEFT IN SITU. THE PROCEDURE WAS COMPLETED. ONE BREAKAGE FRAGMENT OF THE QUESTIONED PLIVIOPORE CAGE WAS RETURNED FOR EXAMINATION. THE PATIENT WAS BEING TREATED FOR SPINAL CHANNEL STENOSIS AND SPONDYLOLISTHESIS LWK 3/4 MEYERDING GRADE II AS WELL AS SLIPPED INTERVERTEBRAL DISC LWK 4/5 LEFT INTRAFORAMINAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277643 PLIVIOPORE SIZ 10 JDN SYNTHES GMBH 3521362

    Patients

    Seq Age Sex Outcome Treatment
    1