BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS2/PASSMED SPINAL SYSTEM - 6.0MM ROD

    MDR report key: 1186013 · Received October 2, 2008

    Report

    Report Number
    1000432246-2008-00003
    Event Type
    Injury
    Date Received
    October 2, 2008
    Date of Event
    November 15, 2007
    Report Date
    September 29, 2008
    Manufacturer
    MEDICREA TECHNOLOGIES
    Product Code
    KWP
    PMA / PMN Number
    K001024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS: THE IMPLANT WAS NOT AVAILABLE FOR EVAL. THE PT HAD AN INFECTION AND THE DR FEELS THERE WAS NO ISSUE RELATED TO THE PRODUCT. THE SURGICAL TECHNIQUE WAS NOT FOLLOWED AS THERE WERE NO SCREWS IN L3 AND THE SCREW ON THE RIGHT IN L5 DID NOT HAVE A NUT HOLDING DOWN THE CLAMP. CONCLUSIONS: BREAKAGES ARE POSSIBLE UNDESIRABLE EFFECTS WHICH ARE DESCRIBED IN THE INSTRUCTIONS FOR USE. THE REPORTED INCIDENT IS NOT A PRODUCT RELATED FAILURE AND DOES NOT QUESTION THE EFFICACY OF THE PASSMED SYSTEM.

    Description of Event or Problem · 1

    THE ROD BROKE ON THE LEFT SIDE JUST ABOVE THE CLAMP AT L4. THE L4 SCREW BROKE ON THE RIGHT SIDE. THERE WAS NO SCREWS IN L3 AND THE SCREW ON THE RIGHT IN L5 DID NOT HAVE A NUT HOLDING DOWN THE CLAMP. THE PT HAD AN INFECTION AND THE DR FEELS THERE WAS NO ISSUE RELATED TO THE PRODUCT. HE WILL REVISE USING THE PASS LP AND THE 6MM RODS. DISTRIBUTOR MENTIONED THAT THE SURGEON DIDN'T FAULT THE SYSTEM. HE ALSO BELIEVES THE SURGEON DIDN'T PUT ONE OF THE NUTS ON THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASS2/PASSMED SPINAL SYSTEM - 6.0MM ROD POSTERIOR PEDICLE SCREW SYSTEM - ROD KWP MEDICREA TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R