BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 2338353 · Received October 14, 2011

    Report

    Report Number
    1000432246-2011-00010
    Event Type
    Injury
    Date Received
    October 14, 2011
    Date of Event
    September 2, 2011
    Report Date
    October 14, 2011
    Manufacturer
    MEDICREA INTL.
    Product Code
    MNI
    PMA / PMN Number
    K080099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: REVIEW OF DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION COULD NOT LEAD TO DEFINE THE PRECISE ROOT CAUSE OF THIS ADVERSE EVENT. THIS EVENT APPEARS TO BE INFECTION. THE ROOT CAUSE COULD NOT BE DEFINED PRECISELY WITH INFO COLLECTED. IMPLANTS USED IN SURGERY INCLUDED: 510(K) K080099, (B)(4): NUT; (B)(4): POLYAXIAL SCREW 4.5MM, LENGTH 30MM; (B)(4): POLYAXIAL SCREW 5.5MM, LENGTH 30MM; (B)(4): POLYAXIAL SCREW 5.5MM, LENGTH 35MM; (B)(4): POLYAXIAL SCREW 5.5MM, LENGTH 40MM; B02235501: STANDARDING CONNECTING CLAMP FOR ROD 5.5; 510(K) K100297, (B)(4): DEROTATION CONNECTOR; 510(K) K100297, (B)(4): COCR ROD 5.5, LENGTH 260MM.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT RETURNED FOR A 6 MONTH POST-OP VISIT. DOCTOR INDICATED THAT THE WOUND HAD ENLARGED IN SIZE AND THAT SURGICAL INTERVENTION WAS REQUIRED TO CLEAR POSSIBLE INFECTION. PT WAS ADMITTED ON (B)(6) 2011 FOR IRRIGATION AND DEBRIDEMENT OF THE WOUND SITE. PT WAS DISCHARGED ON (B)(6) 2011 WITH ORDER TO TAKE PO CIPRO FOR 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASS LP PEDICLE SCREW MNI MEDICREA INTL.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention