BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LENGTH

    MDR report key: 2873945 · Received December 14, 2012

    Report

    Report Number
    2520274-2012-03748
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    September 17, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    PMA / PMN Number
    K103287
    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 AND 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

    (B)(4). DHR REVIEW FOUND 1 NCR (B)(4) FOR DATA ENTRY ERROR IN LIMS PART NO. 21039, LOT 6546787. THERE WAS NO NONCONFORMANCE; NCR WAS WRITTEN FOR INVESTIGATION THAT WAS INADVERTENTLY INITIATED IN LIMS BECAUSE OF AN OPERATOR DATA ENTRY ERROR. NCRS NONCONFORMANCE IS NOT RELEVANT TO COMPLAINT CONDITION. NO OTHER DISCREPANCIES WERE NOTED THAT WOULD BE ASSOCIATED WITH THIS COMPLAINT. THE INVESTIGATION IS ONGOING. (B)(4): PLACEHOLDER.

    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

    A MANUFACTURING EVALUATION WAS CONDUCTED. PRODUCT WAS RECEIVED AS AN ASSEMBLY. SCREW ASSEMBLY HAS VISUALLY OBVIOUS DAMAGE. THE BODY HAS NICKS AND SCRATCHES ON THE INTERNAL AND EXTERNAL SURFACES, AND WEAR IN THE LOCKING GROOVE AND THE LOCKING TABS. THE BODY ALSO HAS WITNESS LINES WHERE THE SLEEVE SLID INTO ITS ASSEMBLED LOCATION. THE SCREW HAS BOTH MISSING ANODIZE ON BONE THREADS AND NICKS AND SCRATCHES ON THE T25 FACE. THE SLEEVE HAS VISUAL DAMAGE ON THE ROD SLOT. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. 04.620.645, 6.0 TI SCREW PERFORMED AS DESIGNED, NO RELEVANCE TO NON-UNION AND BILATERAL BROKEN RODS. NO RELEVANT FEATURES CAN BE IDENTIFIED BY EVALUATOR.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    LEGACY DEPUY CONSULTANT REPORTED PATIENT WITH MULTIPLE PRIOR SPINE SURGERIES FROM T10-ILIUM 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 4 OF 10 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LENGTH PANGEA TM POLYAXIAL SCR MNI SYNTHES USA 6608186

    Patients

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