BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04233

    MDR report key: 3220889 · Received July 11, 2013

    Report

    Report Number
    2520274-2013-04233
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EXACT DATE OF IMPLANT UNKNOWN. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIAGNOSED WITH SPASTIC QUADRIPLEGIA CEREBRAL PALSY, WAS TREATED IN (B)(6) 2013, FOR A RIGHT FEMORAL NECK FRACTURE WITH A OPEN REDUCTION INTERNAL FIXATION OF THE PROXIMAL FEMUR. A 5.0MM PEDIATRIC LOCKING COMPRESSION PLATE AND APPLICABLE SCREWS WERE USED. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON (B)(6) 2013, FOR A FAILED OPEN REDUCTION INTERNAL FIXATION OF RIGHT FEMORAL NECK. NON-UNION OF THE FEMORAL NECK FRACTURE WAS DIAGNOSED AND SPECIMENS WERE TAKEN FROM THE OPERATIVE SITE AND SENT TO THE LAB TO INVESTIGATE POSSIBLE INFECTION. THE HARDWARE WAS REMOVED AND A PROXIMAL RIGHT FEMORAL RESECTION (ALSO KNOWN AS A GIRDLESTONE) PROCEDURE, WAS THEN PERFORMED TO ASSIST WITH PAIN MANAGEMENT. NO OTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319573 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention