BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA BLOCKER

    MDR report key: 2092878 · Received May 11, 2011

    Report

    Report Number
    9617544-2011-00170
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 15, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    K982494
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: THE COMPLAINT ALLEGED THAT THE ENTIRE XIA SYSTEM THAT WAS IMPLANTED LOOSENED AND WOULD GIVE NO FURTHER INFORMATION. THEY LISTED 14 PRODUCTS THAT ALSO ARE INCLUDED IN THE COMPLAINT. FROM PREVIOUS EXPERIENCE, IT IS LIKELY THAT IT IS THE BLOCKERS THAT LOOSENED SO THIS REPORT IS FILED ON THE BLOCKERS BUT THE OTHER ITEMS INCLUDED IN THIS LIST WILL BE EVALUATED IF RECEIVED AND INVESTIGATED AND RE-EVALUATED FOR REPORTABILITY AT THAT TIME. (B)(4), K060361. CUSTOMER STATED THEY ARE NOT RETURNING PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN EVENT RELATED TO THE FAILURE OF THE XIA SYSTEM DUE TO THE LOOSENING OF THE SYSTEM. A PATIENT UNDERWENT AN UNANTICIPATED REVISION SURGERY DUE TO LOOSENING OF THE SYSTEM ON (B)(6) 2011. THE CUSTOMER FORWARDED A FAX WITHOUT CAT# AND LOT CODE AND WITHOUT OTHER ESSENTIAL INFO. THE CUSTOMER WAS CONTACTED BY PHONE AND VIA E-MAIL BUT WASN'T ABLE TO ADD FURTHER INFORMATION. THIS PER WAS RAISED WITH A MINIMUM OF INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA BLOCKER IMPLANT KWP STRYKER SPINE BORDEAUX NA UC2

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O| R (QTY 1, LOT YKD)| XIA LP POLYAXIAL SCREW 6.5X40MM, CAT# 03821640| XIA ROD DIA. 6X120, CAT# 03802120| (QTY 1, LOT #9U3)| (QTY 1, LOT VNU), (QTY 1, LOT WNG)| (QTY 3, LOT UNKNOWN), (QTY 1, LOT A81020)| XIA ROD, CAT# UNKNOWN, (QTY 1, LOT L120)| XIA BLOCKER, CAT# 03756230, (QTY 3, LOT UC2)| (QTY 2, LOT A81020)| XIA LP POLYAXIAL SCREW 6.5X45MM, CAT# 03821645