BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

    MDR report key: 5739677 · Received June 21, 2016

    Report

    Report Number
    2520274-2016-13238
    Event Type
    Injury
    Date Received
    June 21, 2016
    Date of Event
    June 15, 2016
    Report Date
    June 15, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    GWO
    PMA / PMN Number
    PK033868
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    PATIENT LAST INITIAL REPORTED (B)(6). PATIENT DATE OF BIRTH/AGE, GENDER, AND WEIGHT ARE UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN PSI IMPLANT. WITHOUT A VALID PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. THE DEVICE WAS NOT EXPLANTED. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4). UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR THE COMPLAINANT PSI IMPLANT WERE NOT PROVIDED. THE LIKELY 510K, WHICH HAS BEEN ADDED TO THE ASSOCIATED MEDWATCH FIELD, 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 THERE WERE BONE FRAGMENTS PRESENT ON THE PRE-OPERATIVE CT (X-RAY COMPUTED TOMOGRAPHY) SCAN BUT NOT ON THE IMAGES FOR THE IMPLANT DESIGN. THESE BONE FRAGMENTS WERE REMOVED FROM THE PATIENT. WHEN THE SURGEON PLACED THE IMPLANT SO THE TEMPORAL AND FRONTAL AREA FIT, THE PARIETAL AREA SAT PROUD. IF THE SURGEON ADJUSTED THE IMPLANT SO THE PARIETAL AREA FIT, THEN THE TEMPORAL AND FRONTAL AREA SAT PROUD. IT WAS ADDITIONALLY REPORTED THAT THERE WERE DISCREPANCIES BETWEEN THE ACTUAL IMPLANT AND THE IMPLANT MODEL; THE MODEL IMPLANT WAS THINNER THAN THE ACTUAL IMPLANT. THE ACTUAL IMPLANT BEVELED EDGE WAS MUCH MORE PROMINENT THAT THE MODEL IMPLANT. THE POST-OPERATIVE RESULTS WERE REPORTED AS GOOD. IT WAS REPORTED THAT ALTHOUGH THE OUTCOME WAS GOOD, THE SURGEON SPENT THREE (3) HOURS CONTOURING BOTH THE IMPLANT AND THE PATIENT'S SKULL TO ACHIEVE A FIT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOPLASTY PROCEDURE ON (B)(6) 2016. DURING INSERTION OF A PATIENT SPECIFIC IMPLANT (PSI) DEVICE, IT WAS NOTED THAT THE DESIGN WAS SIGNIFICANTLY OFF IN TERMS OF SIZE, RESULTING IN A LARGE DISCREPANCY BETWEEN THE PATIENTSKULL AND THE PSI IMPLANT. IN ORDER FOR THE PSI IMPLANT TO FIT, THE SURGEON NEEDED TO CONTOUR THE PATIENTSKULL. THE PROCEDURE WAS PROLONGED BY THREE (3) HOURS. NO ADDITIONAL INFORMATION PERTAINING TO PATIENT OR PROCEDURAL OUTCOMES WERE AVAILABLE. THIS REPORT IS FOR ONE (1) UNKNOWN PSI IMPLANT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394126 PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE GWO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention