BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRANIOFIX 2 TITANIUM CLAMP 11MM

    MDR report key: 6520774 · Received April 25, 2017

    Report

    Report Number
    9610612-2017-00175
    Event Type
    Injury
    Date Received
    April 25, 2017
    Date of Event
    January 25, 2017
    Report Date
    April 1, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    GXN
    PMA / PMN Number
    K972332
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. IT WAS REPORTED THAT THE PATIENT HAD CRANIOTOMY ON (B)(6) 2016 WITH DURAL IMPLANTED. (LEFT FRONTO-CENTRO-PARIETAL CRANIOTOMY EXCISION OF MENINGIOMA, IMPLANTED DURAL GRAFT AND FIXATION CLIPS.) IT BECAME LIFE THREATENING, HOSPITALIZATION AND REQUIRED INTERVENTION. ON (B)(6) 2017 RETURNED TO OPERATING ROOM FOR INTRACRANIAL INFECTION. OPERATION (PROCEDURE): LEFT CRANIECTOMY, DEBRIDEMENT OF SUBDURAL EMPYEMA. FINDINGS: PURULENT MATERIAL IN THE SUBDURAL SPACE. BONE FLAP, FIXATION CLIPS AND DURAL GRAFT REMOVED. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00175, 9610612-2017-00176.

    Additional Manufacturer Narrative · 1

    ASSOCIATED MEDWATCH: 9610612-2017-00176. PLEASE NOTE: A RETROSPECTIVE REVIEW OF POTENTIAL SERIOUS INJURY COMPLAINTS WAS PERFORMED. THIS MDR WAS IDENTIFIED AND FILED AS PART OF THE REVIEW ACTIVITIES.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO PRODUCT AT HAND BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS OF BOTH LOTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. CONCLUSIONS AND ROOT CAUSE: THE ROOT CAUSE IS MOST PROBABLY USER RELATED. RATIONAL: THE DESCRIBED PROBLEM, CAUSED BY CRANIOFIX FF490T IS NOT KNOWN AT AAG. THE STERILIZATION PROCESS OF THE CRANIOFIX CLAMPS IS TESTED AND VALIDATED. WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES WE ASSUME, THAT THE PROBLEM WAS CAUSED BY THE USED FOREIGN ARTICLE OR OTHER UNKNOWN CIRCUMSTANCES AT THE HOSPITAL. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299656 CRANIOFIX 2 TITANIUM CLAMP 11MM CRANIAL IMPLANTS GXN AESCULAP AG FF490T 52246501

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R