BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 6.35 TI POLY 6 X 40MM

    MDR report key: 3111536 · Received May 14, 2013

    Report

    Report Number
    1526439-2013-17023
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MNH
    PMA / PMN Number
    PK062174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW AND CONCOMITANT DEVICES ARE NOT AVAILABLE FOR EVALUATION. REVIEWS OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED AS THE LOT CODES ARE UNKNOWN. WITHOUT PRODUCT SAMPLES, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. REVIEW OF COMPLAINT DATA FOUND NO EMERGING TRENDS. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. HOWEVER, IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS DUE TO PSEUDOARTHROSIS AT THE L2 DISC SPACE. AS REPORTED, THE HARDWARE DID NOT FAIL AND WAS NOT THE CAUSE OF THE PATIENT'S PSEUDOARTHROSIS. THE PATIENT'S BONE QUALITY IS REPORTED TO BE POOR. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH LUMBOSACRAL RADICULITIS DUE TO A PSEUDOARTHROSIS AT THE L2 DISC SPACE. IT WAS REPORTED THAT THE HARDWARE DID NOT FAIL AND WAS NOT THE CAUSE OF THE PATIENT'S PSEUDOARTHROSIS. THE PATIENT'S BONE QUALITY IS POOR. ALL HARDWARE FROM L2-5 WAS REMOVED AND REPLACED WITH EXPEDIUM 6.35 POLY SCREWS AND RODS FROM L1-4. THE EXPLANTED DEVICES WILL NOT BE MADE AVAILABLE FOR EVALUATION. CONCOMITANT DEVICES: EXPEDIUM POLYAXIAL SCREWS, 179912640 X 1, 179912647 X 2; EXPEDIUM SET SCREWS, 179902000 X 4; MONARCH POLYAXIAL SCREWS, CATALOG NUMBERS UNKNOWN, QTY = 6; TITANIUM RODS, CATALOG NUMBERS UNKNOWN, QTY = 4; ROD TO ROD CONNECTORS, CATALOG NUMBERS UNKNOWN; QTY = 2, MONARCH LOCKING CAPS, CATALOG NUMBERS UNKNOWN, QTY = 6

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213056 EXPEDIUM 6.35 TI POLY 6 X 40MM ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention