BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL SPACER-PR 8MMX22MM 7MM HEIGHT

    MDR report key: 3081853 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-11142
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    SYNTHES (USA
    Product Code
    MQP
    PMA / PMN Number
    K011037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. ORIGINAL FILE NUMBER REPORTED WAS INCORRECT. FILE NUMBER IS (B)(6), NOT (B)(6).

    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.(B)(4)

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING AN L5-S1 POSTERIOR LUMBAR FUSION, THE VERTEBRAL SPACER CRACKED WHEN THE SURGEON WAS TAMPING IT IN. SURGEON REMOVED SPACER AND OPTED FOR BONE GRAFT TO PACK THE AREA. THE PATIENT WAS NOT HARMED. THE CRACKED SPACER WAS DISCARDED BY THE HOSPITAL. THIS IS 1 OF 1 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS 1 OF 1 FOR COMPLAINT FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185235 VERTEBRAL SPACER-PR 8MMX22MM 7MM HEIGHT MQP SYNTHES (USA

    Patients

    Seq Age Sex Outcome Treatment
    1