BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI SD800.419 PEEK IMPLANT

    MDR report key: 3762155 · Received April 21, 2014

    Report

    Report Number
    1000562954-2014-10056
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 25, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    GXN
    PMA / PMN Number
    PK033868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PD EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE 3D PRINT OF THE DEFECT AND THE IMPLANT HAS BEEN PRODUCED AND COMPARED WITH EACH OTHER AND THE RETURNED IMPLANT. THEY FIT PERFECTLY. DEVICE WAS 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS NOT EXPLANTED. DEVICE WAS 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THERE WAS DIFFICULTY WITH THE FIT OF A PATIENT SPECIFIC IMPLANT. THE IMPLANT HAD CONTACT PROPERLY ON ONE SIDE BUT NOT ON THE OTHER, THE PATIENT DID NOT HAVE A MUSCLE OR OTHER SOFT TISSUE INSERTED IN THE DEFECT. THE SURGEON HAD TO CUT THE IMPLANT TO GET IT TO FIT, AND THEN MILLED THE SURFACE BECAUSE THE AESTHETIC RESULT WAS NOT CORRECT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240313 PSI SD800.419 PEEK IMPLANT PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE GXN SYNTHES MEZZOVICO 8813122

    Patients

    Seq Age Sex Outcome Treatment
    1