BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, CRANIOPLASTY PERFORMED

    MDR report key: 4329502 · Received December 15, 2014

    Report

    Report Number
    2520274-2014-15269
    Event Type
    Injury
    Date Received
    December 15, 2014
    Report Date
    December 1, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    GWO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS FOR AN UNKNOWN PEEK IMPLANT /UNKNOWN QUANTITY/ UNKNOWN LOT NUMBER. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE COMPARISON OF POLYETHERETHERKETONE AND TITANIUM CRANIOPLASTY AFTER DECOMPRESSIVE CRANIECTOMY THIEN A, NICOLAS K., ANG K., WANG E, NG I. WORLD NEUROSUGERY. THE OBJECT OF THE STUDY WAS TO CHARACTERIZE COMPLICATION AND FAILURE RATES AND OUTCOMES OF PATIENTS WHO UNDERWENT CRANIOPLASTY WITH POLYETHERETHERKETONE (PEEK) AND TITANIUM IMPLANTS AND TO COMPARE COMPLICATION AND FAILURE RATES BETWEEN THE 2 IMPLANTS. A RETROSPECTIVE COHORT STUDY OF PATIENTS WHO UNDERWENT CRANIOPLASTY WITH PEEK PATIENT SPECIFIC IMPLANT (PEEK OPTIMA-LT; SYNTHES, INC, WEST CHESTER, PENNSYLVANIA, USA) COMPLICATIONS NOTED IN THE PEEK GROUP WERE ONE PATIENT WITH DEEP INFECTION, ONE PATIENT WITH EXPOSED IMPLANT, TWO PATIENTS WITH SEIZURES, ONE PATIENT WITH EXTRADURAL HEMORRHAGE AND THREE IMPLANT FAILURES WITH REVISIONS. CONCLUSION: THE FINDINGS FROM THIS STUDY HIGHLIGHT THAT CRANIOPLASTY IS ASSOCIATED WITH SIGNIFICANT COMPLICATIONS, INCLUDING THE NECESSITY FOR REOPERATION. IT IS HOPED THAT THE INFORMATION IN THIS STUDY WILL PROVIDE BETTER UNDERSTANDING OF THE RISKS ASSOCIATED WITH PEEK AND TITANIUM CRANIOPLASTY AND CONTRIBUTE TO DECISION MAKING BY THE CLINICIAN AND PATIENT. THIS REPORT IS ONE OF TWO FOR (B)(4). THIS IS FOR ONE UNKNOWN PEEK IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821302 PLATE, CRANIOPLASTY PERFORMED GWO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention