BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 3062531 · Received April 17, 2013

    Report

    Report Number
    1000432246-2012-00005
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    July 5, 2012
    Report Date
    August 8, 2012
    Manufacturer
    MEDICREA TECHNOLOGIES
    Product Code
    MNI
    PMA / PMN Number
    K080099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: REVIEW OF DEVICE HISTORY WAS NOT POSSIBLE AS THE LOT NUMBERS WERE NOT PROVIDED. INVESTIGATION COULD NOT LEAD TO DEFINE THE PRECISE ROOT CAUSE OF THIS ADVERSE EVENT. THIS EVENT APPEARS TO BE AN INFECTION. CONCLUSION: THE ROOT CAUSE COULD NOT BE PRECISELY DEFINED WITH INFORMATION COLLECTED. IMPLANTS USED IN SURGERY INCLUDED: 510K K080099. B02130005: NUT. B02214530: POLYAXIAL SCREW, DIAMETER 4.5MM, LENGTH 30MM. B02214535: POLYAXIAL SCREW, DIAMETER 4.5MM, LENGTH 35MM. B02214540: POLYAXIAL SCREW, DIAMETER 4.5MM, LENGTH 40MM. B02215540: POLYAXIAL SCREW, DIAMETER 5.5MM, LENGTH 40MM. B02215035: POLYAXIAL SCREW, DIAMETER 5.0MM, LENGTH 35MM. B02215040: POLYAXIAL SCREW, DIAMETER 5.0MM, LENGTH 40MM. B02216540: POLYAXIAL SCREW, DIAMETER 6.5MM, LENGTH 40MM. B02236001: STANDARD CONNECTION CLAMP FOR 6MM DIAM ROD. B02126024: ROD 6MM DIA, 240 LENGTH. 510K K082577. B99100210: DEROTATION CONNECTOR. 510K K082069. B02242209: SHORT, LUMBAR LAMINAR COUNTERHOOK. B02241106: LARGE, POLYAXIAL PEDICULAR HOOK FOR CLAW. B02240106: LARGE, POLYAXIAL PEDICULAR HOOK. B02240322: LEFT, POLYAXIAL TP HOOK, 11MM.

    Description of Event or Problem · 1

    ON 1419937-2013- 2012 PATIENT ARRIVED FOR HER 6 MONTH POST-OP VISIT COMPLAINING OF PAIN, SCAR APPEARANCE AND DISCHARGE FROM WOUND SITE. ON 1419937-2013- 2012 PATIENT WAS ADMITTED TO HOSPITAL FOR AN IRRIGATION AND DEBRIDEMENT PROCEDURE FOR POSSIBLE DEEP WOUND INFECTION. THERE WA NO SIGN OF INFECTION DURING THE PROCEDURE AND ALL CULTURES WERE NEGATIVE FOR INFECTION. THE PATIENT WAS DISCHARGED AND WILL BE FOLLOWED FOR ANY CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166276 PASS LP PEDICLE SCREW MNI MEDICREA TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other| R