BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI HARD ROD 400MM

    MDR report key: 3130640 · Received May 24, 2013

    Report

    Report Number
    2530088-2013-00815
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: 02/24/2009. REVIEW OF DEVICE HISTORY RECORDS (DHR), PART NUMBER 498.116, SHOWED NO ISSUES DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS IMPLANTED ON AN UNKNOWN DATE IN 2009. A REQUEST FOR THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN MADE. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE PARTS WERE FOUND CONFORMING FOR THE OUTSIDE DIAMETER AND THE RAW MATERIAL TYPE. THE MANUFACTURING EVALUATION FOUND NO NON-NONCONFORMING FEATURES THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IT IS POSSIBLE THAT THE RODS BROKE DUE TO THE PSEUDOARTHROSIS. IF A COMPLETE FUSION DOES NOT TAKE PLACE, THE FATIGUE LOAD IS TRANSFERRED TO THE ROD WHICH WILL EVENTUALLY FATIGUE AND FRACTURE. IT IS UNABLE TO BE DETERMINED IF THE CAUSE OF THE THESE BREAKAGES WAS DUE TO IMPROPER IMPLANT USAGE, PATIENT ACTIVITY LEVEL, AND/OR STRESSES IMPOSED ON THE IMPLANT BY THE SURGEON OR PATIENT. THE ROD DESIGN & MATERIALS WERE REVIEWED AND ARE ADEQUATE FOR THE DEVICE'S INTENDED USE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE IN 2003, THE PATIENT HAD DECOMPRESSION SURGERY WITH NO FUSION. ON AN UNKNOWN DATE IN 2009, A SECOND PROCEDURE OCCURRED WITH FUSION. PATIENT PRESENTED TO SURGEON ON UNKNOWN DATE WITH BACK PAIN. X-RAYS AND EXAMINATION REVEALED A BROKEN ROD ON THE RIGHT SIDE AT APPROXIMATELY L3-L4. THE FUSION WAS REVISED ON (B)(6) 2013 WITH NOTED PSEUDOARTHROSIS AT L3-L4. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232227 6.0MM TI HARD ROD 400MM MNH SYNTHES BRANDYWINE 6043072

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention