BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAVANNAH PEDICLE SCREW SYSTEM

    MDR report key: 2851105 · Received November 19, 2012

    Report

    Report Number
    1067095-2012-00002
    Event Type
    Other
    Date Received
    November 19, 2012
    Date of Event
    December 19, 2011
    Report Date
    November 7, 2012
    Manufacturer
    AMENDIA
    Product Code
    NKB
    PMA / PMN Number
    K072116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RE-EVALUATION OF ASSEMBLY TOLERANCE REVEALED A POTENTIAL FOR THE SADDLE TO INTERFERE WITH THE KNOCKDOWN OF THE CONSTRUCT. THIS COULD OCCUR ON EXTREME WORST CASE DIMENSIONAL ANALYSIS. HOWEVER, WITHOUT THE IMPLANT, THE EXACT CAUSE IS UNDETERMINABLE. MDR SUBMITTED BY : (B)(4). MANUFACTURER'S NOTE: THIS MDR IS BEING FILED AT THIS TIME (LATE) AT THE REQUEST OF THE 3RD PARTY REVIEWER. COMPANY FOLLOWED THEIR QUALITY PROCEDURES FOR REVIEWING THIS INCIDENT AND, AT THAT TIME, IT WAS DETERMINED THAT THIS INCIDENT DID NOT RISE TO THE LEVEL OF FILING AN MDR.

    Description of Event or Problem · 1

    PATIENT HAD SPINE FUSION SURGERY (LEVELS NOT SPECIFIED) IN (B)(6) 2011. DURING THE 4-WEEK FOLLOW-UP VISIT, THE SURGEON WAS ABLE TO SEE ON THE X-RAY THAT THE SET SCREW HAD BECOME DISLODGED FROM THE TULIP. PATIENT HAD NO COMPLICATIONS. REVISION SURGERY WAS APPARENTLY DISCUSSED BUT HAS EITHER NOT BEEN SCHEDULED OR COMPLETED. NO FURTHER FOLLOW-UP IS AVAILABLE OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVANNAH PEDICLE SCREW SYSTEM PEDICLE SCREW SYSTEM NKB AMENDIA SAVANNAH-T MIS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other