BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI SIDE-OPENING SCREW 40MM

    MDR report key: 2604396 · Received June 5, 2012

    Report

    Report Number
    2530088-2012-00311
    Event Type
    Injury
    Date Received
    June 5, 2012
    Report Date
    May 8, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNI
    PMA / PMN Number
    K943725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IT WAS FURTHER REPORTED THAT THERE WAS A FIVE MINUTE DELAY TO THE SURGERY AS A RESULT OF THIS EVENT. PRODUCT CODE IS MNI AND ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES MNH AND KWP. : OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. IMPLANTED ON AN UNKNOWN DATE. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS THE DEVICE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. CONTACT NAME CHANGED TO (B)(6) MANAGER. CORRECTED 510K TO K943725.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT IMPLANTED AT L2-S2 WITH PANGEA AND USS CONSTRUCT ON AN UNKNOWN DATE. PATIENT COMPLAINED OF POSTOP PAIN. REPORTEDLY, SURGEON SUSPECTED A POSSIBLE NON-UNION AT L5-S1 AND RETURNED PATIENT TO OPERATING ROOM ON (B)(6) 2012, FOR REMOVAL AND REVISION. SURGEON CUT THE RODS AND REMOVED ALL HARDWARE AT S1-S2. ALL HARDWARE AT L2-L5 WAS LEFT INTACT. SURGEON REMOVED PART OF TWO RODS. TWO PANGEA SCREWS WERE REMOVED ALONG WITH TWO CAPS FROM S1 AND TWO USS SCREWS, TWO COLLARS, AND TWO NUTS FROM S2. PATIENT WAS REVISED TO MATRIX CONSTRUCT FROM S1-ILIUM. DURING REVISION, THE HEAD BROKE OFF ONE OF THE MATRIX SCREWS WHILE TRYING TO SEAT THE ROD. SURGEON REMOVED THE BROKEN SCREW AND HEAD AND REPLACED WITH ANOTHER SCREW, THEN SEATED ROD AND CAP WITH NO FURTHER PROBLEM. THIS IS THE SEVENTH OF 13 REPORTS SUBMITTED ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS A FIVE MINUTE DELAY TO THE SURGERY AS A RESULT OF THIS EVENT. THIS IS REPORT 7 OF 13 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM TI SIDE-OPENING SCREW 40MM 5.0MM TI SIDE-OPENING SCREW MNI SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKING CAPS| SCREWS| NUTS| COLLARS| RODS