BEUDAMED
    FDA Adverse Event Other Summary report: N

    MALCOLM RAND

    MDR report key: 498191 · Received November 12, 2003

    Report

    Report Number
    MW1030208
    Event Type
    Other
    Date Received
    November 12, 2003
    Date of Event
    February 10, 2003
    Report Date
    November 12, 2003
    Manufacturer
    CMI
    Product Code
    HBL
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/27/04: AS PREVIOUSLY DISCUSSED, THERE APPEAR TO BE TWO OTHER MEDWATCH REPORTS RELATING TO THIS CLAIMED INCIDENT. THEY DIFFER IN STYLE OF HANDWRITING, AND THE EVENTS WHICH ARE CLAIMED TO HAVE OCCURRED. IT IS FURTHER RELATED THAT A VISUAL INSPECTION BY AN "IN HOUSE ENGINEER" NOTED, "DELAMINATION AND CRACKS IN PINS". THE REPORT DOES NOT INDICATE WHETHER THE REPORTER IS REFERRING TO THE HEAD FIXATION SCREWS OF THE HEAD HOLDING DEVICE, OR THE DISPOSABLE PIN TIPS. THE REPORT DOES INDICATE THAT THE DEVICE IS STILL AVAILABLE FOR EVALUATION. WHICHEVER PART OF THE DEVICE IS BEING REFERRED TO AS THE A "PIN" OR "PINS" THE REPORTS CREATE SUBSTANTIAL CONFUSION REGARDING HOW MANY ARE INVOLVED. STANDARD FIXATION WITH THE CXF-1 INCLUDES FOUR POINTS OF ATTACHMENT TO THE SKULL. REPORTS DO NOT INDICATE WHAT IS MEANT BY "CAME OUT", OR HOW MANY POINTS OF FIXATION ARE CLAIMED TO BE INVOLVED. FURTHER CONFUSION IS CAUSED BY THE FACT THAT ONE REPORT RELATES THAT "PIN CAME OUT", WHILE THE OTHER INDICATES "PINS CAME OUT". CMI ATTEMPTED TO CONTACT REPORTER TO DISCUSS THESE ISSUES. THEY WERE REPEATEDLY ADVISED THAT THEY ARE ON MEDICAL LEAVE AND UNAVAILABLE. CMI'S CONSULTANT DID COMMUNICATE WITH SOMEONE, WHO APPARENTLY HAD A CONVERSATION WITH REPORTER AND PROVIDED SOME INFO. ACCORDING TO THEM, THE HOSPITAL IS STILL IN POSSESSION OF THE HEAD FIXATION SCREWS, BUT REFUSES TO RETURN THEM TO CMI FOR INSPECTION. THE AGE OF THE HEAD FIXATION SCREWS IS CLAIMED TO BE UNK. THE DISPOSABLE PIN TIPS INVOLVED IN THE INCIDENT WERE NOT PRESERVED. THEY REFUSED TO DISCLOSE THE IDENTITY OF THE ATTENDING PHYSICIAN INVOLVED IN THE PROCEDURE. UNDER THE CIRCUMSTANCES, IT IS DIFFICULT FOR CMI TO EVALUATE THE INCIDENT WHICH IS CLAIMED TO HAVE OCCURRED. THE ABOVE REFERENCED FACTS ILLUSTRATE THE AMBIGUITY OF THE REPORTS WITH REGARD TO WHICH PARTS OF CMI'S DEVICE ARE CLAIMED TO BE INVOLVED, AND HOW THEY WERE ALLEGEDLY INVOLVED. IF THE UNIVERSITY OF FLORIDA WOULD ALLOW MY CLIENT TO INSPECT THE REMAINING ARTIFACTS, AND AN OPPORTUNITY TO SPEAK WITH THE PHYSICIAN INVOLVED IN THE PROCEDURE, CMI WOULD BE ABLE TO FILE A SUPPLEMENTAL RESPONSE TO YOUR INQUIRY. MFR BELIEVES IT IS INCUMBENT UPON THE REPORTER TO BE FAR MORE SPECIFIC AND COOPERATIVE WITH REGARD TO THIS REPORT.

    Description of Event or Problem · 1

    PIN CAME OUT OF OLD MALCOLM HEAD HOLDER WHEN SURGERY WAS IN PROGRESS, FOR ABOUT 10 MINUTES. CAUSING PT'S HEAD TO MOVE AND BLEEDING FROM SITE. SURGEON PRESENT, HEAD HOLDER CHANGED TO MAYFIELD AND HEAD WAS STAPLED WHERE IT WAS BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALCOLM RAND CRAND X-RAY FRAME HOLDER HBL CMI CXF-1 71128

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other