BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

    MDR report key: 3831672 · Received May 26, 2014

    Report

    Report Number
    2520274-2014-11606
    Event Type
    Injury
    Date Received
    May 26, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD REVISION SURGERY DUE TO A ROD THAT BROKE BETWEEN L5-S1 ON BOTH SIDES DUE TO PSEUDOARTHROSIS. THE ROD BREAKAGE WAS DISCOVERED DURING A VISIT TO THE SURGEON THROUGH MAGNETIC RESONANCE IMAGING (MRI). DURING THE SURGERY, THE CAPS WERE REMOVED AND THE BROKEN ROD WAS REMOVED, ONE LOOSE SCREW WAS REPLACED. THE RODS WERE REPLACED WITH TITANIUM ALUMINUM NIOBIUM (TAN) RODS AND NEW CAPS WERE PLACED. A FINAL TIGHTENING TORQUE WRENCH WAS USED TO FINAL TIGHTEN ALL THE CAPS. A CAGE WAS PLACED THROUGH THE L5-S1 DISC SPACE. A TRANS-CONNECTOR WAS PLACED BETWEEN L5-S1 SCREWS. IT WAS ALSO REPORTED THAT SEVERAL INSTRUMENTS WERE DAMAGED DURING THE BROKEN ROD REVISION SURGERY AND SEVERAL INSTRUMENT TIPS BROKE OFF. THE SCREWS AND TIPS WERE REMOVED FROM THE CAPS OF THE DEVICES, SOME TIPS LANDED IN THE CAPS, AND PATIENT WITH NO HARM TO THE PATIENT. NO PATIENT HARM WAS REPORTED DURING THE REVISION SURGERY. A TIME DELAY OF 15 MINUTES WAS REPORTED. IT WAS REPORTED, THE INSTRUMENTS MAY HAVE BEEN DAMAGED DURING THE PROCESS DUE TO THE DIFFICULT ANGLE OF THE L5-S1 SLOPE. THIS REPORT IS FOR 2 RODS, PART AND LOT NUMBER UNKNOWN THIS IS REPORT 10 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309906 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention