BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03178

    MDR report key: 3150190 · Received June 6, 2013

    Report

    Report Number
    2520274-2013-03178
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 11, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HARDWARE ON (B)(6) 2013 FOR A TWO-LEVEL VERTEBRAL SPACER TR SURGERY AT L3-L5 LEVELS. PATIENT PRESENTED WITH PAIN. X-RAY TAKEN ON AN UNSPECIFIED DATE REVEALED THE TWO MATRIX SCREWS AT L3 BACKED OUT. FOR THE INITIAL SURGERY, IT WAS REPORTED, THE SURGEON PACKED BONE AND THE SPACER WAS BEHIND THE BONE GRAFT; THE SPACER SHIFTED. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REVISION SURGERY. REPORTEDLY, WHILE THE SURGEON WAS REMOVING THE L4 LOCKING CAP ON THE LEFT SIDE OF THE SPINE USING THE STRAIGHT TIP DRIVER T25, THE TIP OF THE DRIVER BROKE. SURGEON REMOVED THE FRAGMENT WITH A PITUITARY INSTRUMENT. THE SURGEON TRIED TO REMOVE THE LOCKING CAP WITH ANOTHER STRAIGHT TIP DRIVER T25 AND THE TIP OF THE DRIVER BROKE. THE SURGEON WAS REMOVED THE FRAGMENT WITH A BAYONET INSTRUMENT. THE SURGEON THEN TRIED TO REMOVE THE LOCKING CAP WITH A T-HANDLE STARDRIVE SHAFT AND THE SHAFT BROKE IN HALF. IT WAS REPORTED WHILE THE SURGEON WAS USING THE ROD BENDER WITH SILICONE HANDLES FOR CONTOURING THE NEW RODS, THE HANDLES BECAME STUCK. ANOTHER INSTRUMENT WAS USED TO BEND THE RODS. THE SURGEON REMOVED THE T-PLIF SPACER, SCREWS, AND RODS AT L3-4 LEVEL. REPORTEDLY, THE T-PLIF SPACER WAS REMOVED DUE TO THE IMPLANT SHIFTING. THE PATIENT WAS REVISED WITH TWO NEW SCREWS AND RODS. TWO ADDITIONAL SCREWS WERE ADDED TO THE CONSTRUCT AT THE ILEUM LEVEL. REPORTEDLY THERE WAS EXTENDED TIME OF TWO HOURS DUE TO THE DEVICE MALFUNCTION. THIS REPORT IS FOR AN UNKNOWN VERTEBRAL SPACER. THIS IS 9 OF 9 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251024 MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention