BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI SD800.427 PEEK IMPLANT

    MDR report key: 4838613 · Received June 11, 2015

    Report

    Report Number
    2530088-2015-10474
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 27, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    GXN
    PMA / PMN Number
    PK053199
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE NOT REPORTEDLY EXPLANTED. DHR REVIEW ¿ REVIEWED SCANNED DOCUMENTATION IN THE DHR FOR PSI DEVICE SD800.427 (9800966). DOCUMENTATION SHOWS THIS DEVICE WAS MANUFACTURED, ETCHED, INSPECTED, CLEANED AND FORWARD FOR PLASMA TREATMENT AS PER MODEL SPECIFICATIONS SUPPLIED BY CMF PRODUCT DEVELOPMENT ON 1 MAY 2015. NO INCONSISTENCIES WERE FOUND DURING THESE PROCESSES. THERE WERE NO NCR¿S ISSUED AGAINST THIS WORK ORDER. THERE WERE NO ISSUES WITH RAW MATERIAL. 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 THERE WAS AN ISSUE WITH THE FIT OF PATIENT SPECIFIC IMPLANT (PSI). THE IMPLANT HAD TO BE BURRED ROUGHLY 6 MM AROUND THE ORBIT AND THE TEMPORAL REGION TO MAKE IT FIT TO BE IMPLANTED. THERE WAS A DELAY OF 20 TO 30 MINUTES IN SURGERY. THE SURGERY WAS COMPLETED WITH NO FURTHER SURGICAL INTERVENTION REQUIRED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383189 PSI SD800.427 PEEK IMPLANT PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE GXN SYNTHES BRANDYWINE 9800966

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention