BEUDAMED
    FDA Adverse Event Summary report: N

    PASS LP

    MDR report key: 3062535 · Received April 17, 2013

    Report

    Report Number
    1000432246-2012-00006
    Date Received
    April 17, 2013
    Date of Event
    March 15, 2012
    Report Date
    September 17, 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: THE EVAL OF THE X-RAY DID NOT REVEAL ANY ADVERSE EFFECT OR DISLODGING. CONCLUSION: NO CONCLUSION COULD BE MADE AS INSUFFICIENT INFO IS AVAILABLE TO DEFINE PRECISE ROOT CAUSE OF THIS ADVERSE EVENT. NO INTERVENTION HAS BEEN REQUIRED NOR HAS THE PT EXHIBITED ANY NEGATIVE EFFECTS BECAUSE OF THE BROKEN DEVICE. IMPLANTS USED IN SURGERY INCLUDED: B02130005: NUT, B02214535: POLYAXIAL SCREW, DIAMETER 4.5 MM, LENGTH 35 MM, B02214540: POLYAXIAL SCREW, DIAMETER 4.5 MM, LENGTH 40 MM, B02215540: POLYAXIAL SCREW, DIAMETER 5.5 MM, LENGTH 40 MM, B02215040: POLYAXIAL SCREW, DIAMETER 5.0 MM, LENGTH 40 MM, B02126026: ROD 6 MM DIA, 260 LENGTH, B02236001: STANDARD CONNECTOR FOR 6 MM DIAMETER ROD; 510K K082577, B99100210: DEROTATION CONNECTOR; 510K K082069, B02240106: PEDICLE HOOK, B02242209: SHORT LUMBAR LAMINAR COUNTERHOOK, B02241106: LARGE, POLYAXIAL PEDICULAR HOOK.

    Description of Event or Problem · 1

    AT THE 3 MONTH F/U, THE X-RAY REVEALED THAT ONE COUNTER HOOK PLACED AT THE TOP OF THE CONSTRUCT WAS BROKEN. PT WAS ASYMPTOMATIC. SURGEON DECIDED TO LEAVE THE IMPLANT IN THE PT, AND MONITOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164378 PASS LP SPINAL HOOK, PRODUCT CODE: KWP MNI MEDICREA TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other