BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO CODE AVAILABLE

    MDR report key: 5486102 · Received March 8, 2016

    Report

    Report Number
    2520274-2016-11529
    Event Type
    Injury
    Date Received
    March 8, 2016
    Report Date
    February 19, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    GXN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DATE OF POST-OPERATIVE SYMPTOM ONSET IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN PATIENT SPECIFIC IMPLANT (PSI). WITHOUT A VALID PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. THE ORIGINAL IMPLANT PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. THE DEVICE HAS NOT BEEN EXPLANTED. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PATIENT: TO REPORT THE POTENTIAL ALLERGIC REACTION EXPERIENCED BY THE PATIENT. UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR THE COMPLAINANT PSI ARE UNKNOWN. A POTENTIAL 510K NUMBER FOR THE DEVICE IS K033868. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT MAY BE EXPERIENCING AN ALLERGIC REACTION TO A PATIENT SPECIFIC IMPLANT (PSI) COMPOSED OF POLYETHERETHERKETONE (PEEK) MATERIAL. AN UPDATE FROM THE REPORTER WAS RECEIVED ON (B)(6) 2016 INDICATING THAT THE OPINION IS THAT THE ALLERGIC REACTION IS NOT DUE TO THE SYNTHES IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) UNKNOWN PSI DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143215 NO CODE AVAILABLE GXN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention