BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SPINE

    MDR report key: 2220157 · Received August 15, 2011

    Report

    Report Number
    2520274-2011-00554
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. CLASSIFICATION CODES: KWQ, MNH, MNI, NKB. DATE REPORTED IN ERROR NO WAY TO KNOW WHEN SCREW AND BONE WAS COMPROMISED. CONCOMITANT DEVICE REPORTED IN ERROR; NO CONCOMITANT DEVICE.

    Description of Event or Problem · 1

    PT STATUS POST POSTERIOR LUMBAR FUSION L5-S1 IMPLANTED (B)(6) 2011 RETURNED TO DIFFERENT SURGEON COMPLAINING OF SEVERE PAIN. AN X-RAY SHOWED A SCREW WAS COMPROMISING THE FORAMEN, LEVEL UNK. PT WAS REVISED ON (B)(6) 2011 WITH SURGEON NOTING THE ENTIRE CONSTRUCT NEEDED TO BE REMOVED AS THE IMPLANTING SURGEON COMPROMISED THE BONE AREA. SURGEON REMOVED 4 LOCKING CAPS, 4 SCREWS AND TWO RODS. AS SURGEON WAS REMOVING THE LOCKING CAPS TWO T-25 STARDRIVE SHAFTS STRIPPED. THE REMOVAL WAS COMPLETED WITH THE SURGEON NOT REVISING THE PT TO ANY HARDWARE. SURGEON NOTED, PT DOES NOT WANT ADD'L SURGERY. THIS IS SIX OF TEN REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS FOR AN UNKNOWN SPINE PART. THIS REPORT IS 6 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK - SPINE LOCKING CAP KWP SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREW| ROD