BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM/6.0MM TI TAPERED ROD 500MM

    MDR report key: 3182677 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03626
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K100634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. THIS DEVICE WAS USED FOR TREATMENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS WAS NOT POSSIBLE SINCE WE ARE NOT AWARE OF THE LOT NUMBER. THE CROSS SECTION SURFACES SHOW NO IRREGULARITIES. UNFORTUNATELY THE INFORMATION GIVEN DID NOT PROVE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. THEREFORE WE HAVE TO ASSUME THAT MECHANICAL OVERLOADING OVER TIME HAS RESULTED IN THE BREAKAGE OF THE LEFT ROD. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT INITIALLY UNDERWENT A PRIMARY T11 ILIUM POSTERIOR FUSION WITH PANGEA AND A FOUR LEVEL L2-3 L3-4 AND L5-S1 WITH PLIVIOA ON (B)(6) 2011. ON (B)(6) 2013, REVISION SURGERY TOOK PLACE FOR A NON-UNION AND BROKEN POSTERIOR RODS AT L5-S1. THE CONSTRUCT WAS REVISED AT THAT TIME TO INCLUDE AN ALIF AT L5/S1 AND ILIAC SCREWS. IN (B)(6) 2013, THE PATIENT PRESENTED WITH A BROKEN ROD ON THE LEFT SIDE BETWEEN L5 AND THE ILIAC SCREW. SHE WAS BROUGHT BACK TO SURGERY ON (B)(6) 2013 TO REPLACE BOTH RODS WITH HARD RODS ALONG WITH SHORTER BRACING RODS. THIS COMPLAINT INCLUDES 3 CONCOMITANT UNKNOWN SCREWS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SEE RELATED COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282841 5.5MM/6.0MM TI TAPERED ROD 500MM NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention