BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS CANNULATED MODULAR AWL

    MDR report key: 1633428 · Received March 12, 2010

    Report

    Report Number
    9617544-2010-00107
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    February 19, 2010
    Report Date
    February 18, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HWJ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    DURING INSPECTION OF THE LOANER INSTRUMENTS RETURNED FROM THE CUSTOMER, IT WAS FOUND THAT THE TIP OF THE AWL CRACKED. WE COULD NOT FIND WHICH HOSP USED THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS CANNULATED MODULAR AWL INSTRUMENT HWJ STRYKER SPINE BORDEAUX NA 08A084

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK