BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI HARD ROD 400MM

    MDR report key: 2873925 · Received December 14, 2012

    Report

    Report Number
    2520274-2012-03987
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    September 17, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. AS STATED IN THE COMPLAINT DESCRIPTION, IT IS POSSIBLE THAT THE RODS BROKE DUE TO THE NON-FUSION. IT IS UNABLE TO BE DETERMINED IF THE CAUSE OF 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 DEVICES INTENDED USE. THE CONNECTORS THAT MIGRATED POST-OPERATIVELY WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE 498.116, 6.0MM TI HARD ROD 400MM, LOT NUMBER 6363277 WAS RECEIVED WITH TOOL MARKS AND WORN ANODIZE INDICATIVE OF USE. THE ROD IS CUT AND BENT ON THE CUT END AWAY FROM THE LASER MARKING. THE LASER MARKING IS LEGIBLE. THE ROD WAS CONFORMING FOR THE OUTSIDE DIAMETER AND THE RAW MATERIAL TYPE WAS VERIFIED AS TITANIUM USING NITON03. A REVIEW OF THE DEVICE HISTORY RECORD FOR 498.116, 6.0MM TI HARD ROD 400MM, SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    LEGACY DEPUY CONSULTANT REPORTED PATIENT WITH MULTIPLE PRIOR SPINE SURGERIES FROM T10-ILLIUM WAS RETURNED TO OR FOR REVISION OF DEPUY HARDWARE. HE ALSO REPORTED THAT THE DEPUY HARDWARE WAS IMPLANTED IN (B)(6) 2012 FOR REPLACEMENT OF LEGACY SYNTHES RODS. THE SYNTHES RODS, REPORTEDLY 2X 6MM PANGEA RODS PLUS 8 UNKNOWN SCREWS WERE REMOVED ON (B)(6) 2012 BECAUSE X-RAYS ON UNKNOWN DATE REVEALED NON-UNION AND BILATERAL BROKEN RODS AT L3-L4. PATIENT REVISED TO COCR RODS FROM L3 TO PELVIS, WITH SIDE TO SIDE CONNECTORS TO LINK OLD RODS MORE CRANIALLY. PATIENT WAS RETURNED TO OR ON (B)(6) 2012 AFTER X-RAYS SHOWED CONNECTORS SLID FROM ORIGINAL POSITION AFTER IMPLANTATION. SURGEON REMOVED 2 CONNECTORS, ROD SEGMENTS AND SYNTHES SCREWS TO ALLOW REPLACEMENT WITH LARGER DEPUY SCREWS. PATIENT WAS ALSO REVISED TO COCR RODS FOR THE ENTIRE CONSTRUCT, FROM T10 TO THE PELVIS, WITHOUT CONNECTORS. THIS IS 1 OF 10 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS #1 OF 18 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI HARD ROD 400MM COCR ROD MNH SYNTHES BRANDYWINE 6363277

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention ROD, SCREWS