BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORACLE CAGE 55*22 H15 8° PEEK

    MDR report key: 3171651 · Received June 15, 2013

    Report

    Report Number
    1719045-2013-01565
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    February 27, 2012
    Report Date
    March 8, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MAX
    PMA / PMN Number
    K072791
    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)(4): DEVICE HISTORY RECORD REVIEW: A REVIEW OF SYNTHES DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.(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. EXPIRATION DATE REPORTED INCORRECTLY IN PREVIOUS FU; EXPIRATION DATE IS 06/2019.

    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). THE MEASURABLE DIMENSIONS CORRESPOND WITH THE DRAWINGS AND THE AO-ASIF SPECIFICATIONS. THE RAW MATERIAL TEST AND THE CERTIFICATE AND THE PRODUCTION DOCUMENTS SHOWED THAT THERE WERE NO DEVIATIONS IN REGARDS OF THE MATERIAL ANALYSIS, TENSILE STRENGTH, STRUCTURAL STABILITY AND THE PRODUCTION. THE CAUSE IS UNKNOWN. THERE IS EVIDENCE THAT THE BREAK OF THE CAGE WAS DUE TO EXCESSIVE MECHANICAL FORCE DURING THE INSERTION - OVER-STRESS. NO PRODUCT ERROR COULD BE DETERMINED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2012, THE ORACLE CAGE BROKE WHEN INSERTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272633 ORACLE CAGE 55*22 H15 8° PEEK MAX SYNTHES MONUMENT 6115471

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR