BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 12DEG-STER

    MDR report key: 3031554 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-10688
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    April 16, 2012
    Report Date
    April 16, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MAX
    PMA / PMN Number
    K072253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AWARENESS DATE IS (B)(6) 2012. NEW INFORMATION WAS RECEIVED (B)(4) 2013. A BMP CRUSHED CANCELLOUS BONE GRAFT WAS USED DURING THE PROCEDURE. BRACING FOR ONE MONTH WAS PRESCRIBED POST-OPERATIVELY.

    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 DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE MANUFACTURING VISUAL EVALUATION NOTED ONE ARM OF THE PEEK PART WAS BROKEN OFF AND THEREFORE THE TITANIUM PART WAS SEPARATED FROM THE IMPLANT. THE INVESTIGATION FOUND THE FRACTURED FACE IS HOMOGENOUS, INDICATING MATERIAL CONFORMITY. THE RELEVANT DIMENSIONS WERE CHECKED AS FAR AS POSSIBLE, AND FOUND THEM TO BE WITHIN SPECIFICATIONS. HOWEVER, DUE TO THE DAMAGE EXHIBITED BY THE PRODUCT, NOT ALL DIMENSIONS COULD BE MEASURED, THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. THE PRODUCT DEVELOPMENT EVALUATION FOUND NO DESIGN RELATED ISSUES. THE SLIGHT DEFORMATIONS NOTED AROUND THE CENTER HOLE ARE AN INDICATION THAT TOO MUCH LATERAL STRESS, POSSIBLY IN COMBINATION WITH A HAMMER BLOW, DURING THE INSERTION CAUSED THE BREAKAGE OF ON ARM OF THE PEEK PART. HOWEVER, THERE WERE NO DETAILS OF THE INSERTION PROCEDURE PROVIDED AND THEREFORE THE EXACT CAUSE CAN NOT BE DEFINED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYNFIX PROCEDURE AT L4 TO S1 WHILE INSERTING THE IMPLANT INTO DISC SPACE THE IMPLANT BROKE. THE ARM THAT WRAPS AROUND IMPLANT CAME OFF. THE IMPLANT WAS REMOVED AND THE TAN PLATE CAME OFF THE PEEK. ALL FRAGMENTS WERE RETRIEVED. THE SURGEON SELECTED ANOTHER IMPLANT AND COMPLETED PROCEDURE WITH NO FURTHER PROBLEM.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135271 SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 12DEG-STER MAX SYNTHES GMBH 2780612

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR