BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOCKING SCREW

    MDR report key: 5457134 · Received February 24, 2016

    Report

    Report Number
    2520274-2016-11254
    Event Type
    Injury
    Date Received
    February 24, 2016
    Report Date
    February 2, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    PK142838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INITIALS ARE (B)(6). PATIENT WEIGHT WAS NOT AVAILABLE FOR REPORTING. EVENT DATE: UNKNOWN. ADDITIONAL DEVICE PRODUCT CODE IS NKG. NKG, COMMON NAME ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION, COULD NOT BE ENTERED AS PRIMARY PRODUCT CODE DUE TO SYSTEM LIMITATIONS. PLEASE NOTE THAT ALTHOUGH THIS DEVICE DESCRIPTION STATES THIS DEVICE IS A SCREW, THIS DEVICE IS A LOCKING CAP. (B)(4), LOT NUMBER UNKNOWN. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. 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. MFR: UNKNOWN. 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 REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 BECAUSE THE SCREWS AT THE RIGHT LEVELS T1 AND T2 AND LEFT LEVEL C2 WERE NO LONGER SECURED TO THE ROD. IT WAS DISCOVERED THAT THE ASSOCIATED LOCKING CAPS WERE NO LONGER SECURE AND WERE LOOSE WHICH IS WHAT CAUSED THE RODS TO BECOME UNSECURED FROM THE SCREWS. THE PATIENT INITIALLY UNDERWENT A LEVEL C2 ¿ T2 POSTERIOR CERVICAL FUSION ON (B)(6) 2015 USING SYNAPSE 4.0MM RODS AND ASSOCIATED HARDWARE. ON AN UNKNOWN DATE, AN X-RAY REVEALED THAT THE ROD WAS NO LONGER SECURED. DURING THE (B)(6) 2016 REVISION SURGERY, THE SURGEON REMOVED ALL THE LOCKING CAPS AND EXISTING RODS ALONG WITH THE LEFT C2 3.5MM SCREW AND REPLACED IT WITH A 4.0MM SCREW. THE SURGEON ALSO REMOVED THE T1 AND T2 SCREWS AND REPLACED THEM WITH SYNTHES UNIVERSAL SPINE SYSTEM DUAL OPENING SCREWS. THE SURGEON THEN CUT AND CONTOURED NEW 4.0MM AND 6.0MM RODS AND CONNECTED THEM TO THE SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARM. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115901 TI LOCKING SCREW APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention