BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP - LIAPASS

    MDR report key: 3266557 · Received March 29, 2013

    Report

    Report Number
    1000432246-2013-00004
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MEDICREA TECHNOLOGIES
    Product Code
    MNI
    PMA / PMN Number
    K062136
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: REVIEW OF DEVICE HISTORY RECORDS WAS ONLY POSSIBLE ON THE LIGAPASS DEVICE (B08106010). COMPLIANCE WITH REQUIRED SPECIFICATIONS WAS FOUND. THE LOT NUMBER OF THE OTHER DEVICES WAS NOT PROVIDED. THE INVESTIGATION COULD NOT LEAD TO DEFINE THE PRECISE ROOT CAUSES OF THIS ADVERSE EVENT. THIS EVENT APPEARS TO BE INFECTION. THE ROOT CAUSE COULD NOT BE PRECISELY DETERMINED WITH THE INFO COLLECTED. IMPLANTS USED IN SURGERY INCLUDED: B02214540 - POLYAXIAL SCREW 4.5MM X 40MM. PMA 510K - K062136 - B02215530 - POLYAXIAL SCREW 5.5MM X 30MM; B02215535 - POLYAXIAL SCREW 5.5MM X 35MM; B02215540 - POLYAXIAL SCREW 5.5MM X 40MM; B02216530 - POLYAXIAL SCREW 6.5MM X 30MM; B02216535 - POLYAXIAL SCREW 6.5MM X 35MM; B02216540 - POLYAXIAL SCREW 6.5MM X 40MM; B02216545 - POLYAXIAL SCREW 6.5MM X 45MM; B02216550 - POLYAXIAL SCREW 6.5MM X 50MM; B02217560 = POLYAXIAL SCREW 7.5MM X 60MM. PMA 510K - K123138 - B02130005 - NUT; B02236001 - STANDARD CONNECTOR FOR 6MM ROD. PMA 510K K082577 - B99100210 - DEROTATION CONNECTOR. PMA 510K - K083308 - B02236040 - OFFSET CONNECTOR FOR 6MM ROD. PMA 510K K112736 - B08106010 - LIGAPASS LOT 12E0134 EXPIRATION DATE 05/2017.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT BEGAN NOTICING INCREASED PAIN IN HER LOWER BACK AND SAW STAINED BEDSHEETS. ON (B)(6) 2013, THE PT WAS SEEN BY THE SURGEON'S PA-C IN THE CLINIC. SHE HAD APPROXIMATELY A 3CM AREA OF THE DISTAL WOUND WHICH WAS DRAINED PURULENT MATERIAL. THERE WAS SOME ERYTHEMA AROUND THE AREA. OTHERWISE, NO EVIDENCE OF DEEP INFECTION OR TRACKING WOUND. AT THAT POINT IN TIME, IT WAS FELT BEST TO ADMIT THE PT TO THE HOSPITAL AND SCHEDULE AN I&D. SHE WAS ADMITTED AND AN MRI WAS DONE. THIS SHOWED AN INFECTION OF THE SUBCUTANEOUS TISSUE. IT DID NOT APPEAR THAT THE INFECTION TRACKED DEEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131329 PASS LP - LIAPASS POSTERIOR PEDICLE SCREW SYSTEM MNI MEDICREA TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention