BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEEK CUSTOMIZED CRANIAL IMPLANT KIT, XL

    MDR report key: 7919658 · Received September 28, 2018

    Report

    Report Number
    0008010177-2018-00092
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    September 6, 2018
    Report Date
    March 19, 2019
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    GWO
    UDI-DI
    04546540730794
    PMA / PMN Number
    K121153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, BECAUSE THE INFORMATION PROVIDED WAS NOT SUFFICIENT. THE DEVICE HISTORY RECORD FOR THE ¿PEEK CUSTOMIZED CRANIAL IMPLANT KIT, XL¿, CATALOG # 78-10040, LOT CODE # 1803201008 INDICATES 1 UNIT WAS MANUFACTURED TO SPECIFICATION AND ACCEPTED INTO FINAL STOCK ON 2018-APR-03 WITH NO REPORTED DISCREPANCIES. TO ENSURE THAT THE IMPLANT DIMENSIONS ARE MANUFACTURED ACCORDING TO SPECIFICATION, FOR EACH CUSTOMIZED IMPLANT A 100% CONTROL IS PERFORMED THROUGH STRUCTURED LIGHT SCANNING. THIS TEST WAS SUCCESSFULLY PASSED. ALSO A FITTING TEST WITH THE CORRESPONDING HOST BONE WAS PASSED. WHILE THE PREOPERATIVE CT SCAN WAS PERFORMED ON (B)(6) 2018, THE CRANIOPLASTY DID NOT TAKE PLACE UNTIL THE RECOMMENDED DATE OF (B)(6) 2018, BUT WAS PERFORMED ON (B)(6) 2018. IN THIS CASE THE SCAN AGE WARNING WITHIN THE DESIGN PROPOSAL IS APPLICABLE INCLUDING THE REMARK THAT ¿IMPLANT FIT MAY NOT BE OPTIMAL AND INCREASED INTRA-OPERATIVE IMPLANT MODIFICATION MAY BE REQUIRED AND SHOULD BE EXPECTED¿. HOWEVER THIS DOES NOT COMPLETELY EXPLAIN THE REPORTED ¿IMPLANT IS TOO FLAT¿. THE OBTAINED INFORMATION WAS NOT SUFFICIENT TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. FOR A PROFOUND ASSESSMENT OF THIS CASE A POSTOPERATIVE CT SCAN IS CRUCIAL. SHOULD THIS SCAN BE DELIVERED IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED FOR FURTHER ASSESSMENT. BASED ON THE PERFORMED INVESTIGATION AND THE DHR REVIEW INCLUDING A 100% DIMENSIONAL CONTROL OF THE IMPLANT THROUGH STRUCTURED LIGHT SCANNING THERE IS NO INDICATION FOR A NOT CORRECTLY WORKING PRODUCT OR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. THEREFORE NO FURTHER CORRECTIVE AND / OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THAT TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOM IMPLANT DID NOT FIT THE WAY THE SURGEON WANTED. PER THE SURGEON, "IT WAS TOO FLAT". THE PROCEDURE WAS COMPLETED BY THE SURGEON BURRING DOWN THE POSTERIOR PORTION OF THE CCI TO REDUCE THE GAP AND TO CREATE A LESS PALPABLE SHAPE.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOM IMPLANT DID NOT FIT THE WAY THE SURGEON WANTED. PER THE SURGEON, "IT WAS TOO FLAT". THE PROCEDURE WAS COMPLETED BY THE SURGEON BURRING DOWN THE POSTERIOR PORTION OF THE CCI TO REDUCE THE GAP AND TO CREATE A LESS PALPABLE SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761886 PEEK CUSTOMIZED CRANIAL IMPLANT KIT, XL IMPLANT GWO STRYKER LEIBINGER FREIBURG 1803201008 04546540730794

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention