BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IEXP DDV TI SLOTTED CONN STRT

    MDR report key: 3093650 · Received May 6, 2013

    Report

    Report Number
    1526439-2013-16555
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 22, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK101070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED S1 CONNECTOR AND OTHER REMOVED CONNECTORS FOUND SEVERAL WEAR AND TEAR MARKS ON THE FACES OF THE CONNECTORS. NO DEVICE DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED DURING EVALUATION OF PRODUCT. RESULTS OF THE EXAMINATION OF X-RAY IMAGES APPEAR TO INDICATE CONNECTOR LOOSENING. A REVIEW OF THE DHR ACKNOWLEDGED THAT NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD¿VE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. ALTHOUGH NO DEFINITIVE CONCLUSIONS CAN BE MADE, CONNECTOR LOOSENING MAY HAVE OCCURRED DUE TO THE LACK OF WASHER PLACEMENT WITHIN THE CONSTRUCT. A TOTAL OF TWO WASHERS WILL FIT BELOW A SLOTTED CONNECTOR ON A PEDICLE BOLT AS INDICATED IN THE SURGICAL TECHNIQUE. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT X-RAYS REVEALED THAT THE SLOTTED CONNECTOR ON LEFT S1 CAME LOOSE. REVISION SURGERY WAS PERFORMED AND THE SLOTTED CONNECTOR AND CONCOMITANT DEVICES WERE EXPLANTED. CONCOMITANT DEVICES = ADDITIONAL SLOTTED CONNECTORS, 175450010 X 7; PRE-LORDOSED RODS, 179972095 X 2; MCC J-HOOK FOR ROD, 175430635 X 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196383 IEXP DDV TI SLOTTED CONN STRT ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE BDF4VSN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention