BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNESYS SET SCREWS

    MDR report key: 2115214 · Received April 14, 2011

    Report

    Report Number
    9617297-2011-00001
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 11, 2011
    Manufacturer
    U&I CORP.
    Product Code
    NQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    U&I CORP IS AWAITING RETURN OF THE DEFECTIVE DEVICE FOR FURTHER INVESTIGATION, BUT ALL RECORDS OF THIS LOT SHOWED THAT THE DEVICE MET ALL REQUIREMENTS SPECIFIED ON QUALITY DOCUMENTS.

    Description of Event or Problem · 1

    PT S/P L3-L4 DYNAMIC STABILIZATION AND L4-L5 INTERBODY FUSION WITH PEDICLE SCREWS. RECENTLY SEEN FOR COMPLAINTS OF CONTINUED BACK PAIN. PLAIN X-RAYS REVEALED EVIDENCE OF BACK-OUT OF THE INTERBODY CAGES AT L4-L5 ALONG WITH HARDWARE FAILURE OF L5 SCREWS AND EVIDENCE OF LEFT SCREW FRACTURE AND RIGHT-SIDED LOOSENING. SURGERY PERFORMED ON (B)(6) 2011; RE-EXPLORATION OF L3-S1, REVISION OF HARDWARE AND L4-L5 INTERBODY FUSION CAGES, L5-S1 LAMINECTOMY, PLACEMENT OF L5 AND S1 PEDICLE SCREW, L4-L5 AND L5-S1 RIGID FIXATION AND L3-L4 DYNAMIC STABILIZATION. INTRAOPERATIVE FINDINGS: LEFT L5 SCREW WAS REMOVED AND NOTED TO BE FRACTURED AT MID-SHAFT. RIGHT L5 SCREW WAS NOTED TO BE LOOSE BUT INTACT UPON REMOVAL. PT TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNESYS SET SCREWS PEDICLE SCREW 6.0X50 NQP U&I CORP. NA A08K079

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention