BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI SIDE-OPENING SCREW 40MM

    MDR report key: 3922087 · Received July 9, 2014

    Report

    Report Number
    2520274-2014-12431
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: (B)(6) 2011. PATIENT HAS ADJACENT LEVEL DEGENERATIVE ISSUES. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON PERFORMED A POSTERIOR L5-S1 LUMBAR FUSION ON (B)(6) 2011 ON THE PATIENT USING SYNTHES UNIVERSAL SPINE SYSTEM (USS) TITANIUM. AT AN UNKNOWN TIME, THE PATIENT DEVELOPED ADJACENT DEGENERATIVE ISSUES AT THE L4-5 LEVEL. THE SURGEON PERFORMED THE REVISION SURGERY ON (B)(6) 2014 TO REMOVE THE L5-S1 (USS) HARDWARE AND REPLACED IT WITH (USS) TITANIUM AND USED SCREWS THAT WERE 1MM LARGER IN DIAMETER. HE USED A (USS) VARIABLE ANGLE SCREW III SCREW AT THE RIGHT L5 BECAUSE THE OFFSET BETWEEN THE L4 AND S1 SCREW WAS TOO GREAT (NEEDED A POLYAXIAL SCREW) AND THEN PERFORMED THE DECOMPRESSION. HE THEN CONNECTED THE RODS, AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO ISSUES WITH THE OLD HARDWARE. THIS COMPLAINT INVOLVES 8 DEVICES. THIS REPORT IS 1 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401682 6.0MM TI SIDE-OPENING SCREW 40MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention