BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREMER SKULL PIN

    MDR report key: 1001829 · Received February 25, 2008

    Report

    Report Number
    1526439-2008-00052
    Event Type
    Injury
    Date Received
    February 25, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    HBL
    PMA / PMN Number
    K915800
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WAS WRITTEN IN 2005. A REVIEW OF COMPLAINTS FROM 01/2001 TO DATE FOUND NO ISSUE OF THIS NATURE REPORTED FOR A PATIENT IN ANOTHER COUNTRY. AS NO CONNECTION COULD BE MADE TO A KNOWN EVENT, A COMPLAINT WAS OPENED TO DOCUMENT THIS EVENT. REPORT STATES THAT THE PATIENT HAS ANKYLOSING SPONDYLITIS AND THAT THE QUALITY OF BONE IS LIKELY DEFICIENT. THE SKULL PINS ARE SUPPLIED WITH TORQUE LIMITING CAPS TO PREVENT OVER PENETRATION. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. BASED ON THE INFORMATION, IT APPEARS LIKELY THAT THE PATIENT'S BONE QUALITY WAS A CONTRIBUTING FACTOR IN THIS EVENT.

    Description of Event or Problem · 1

    A MEMBER OF DEPUY SPINE WAS PERFORMING A LITERATURE REVIEW AND NOTED A 2005 ARTICLE THAT MENTIONED A ADVERSE EVENT INVOLVING THE BREMER HALO. THE CASE REPORT STATES THAT A PATIENT WHO WAS FITTED WITH A BREMER HALO AND VEST PRESENTED AT THE EMERGENCY ROOM EIGHT WEEKS OUT DUE TO SHIFTING OF THE HALO. HIS ONLY COMPLAINT WAS A SEVERE HEADACHE. THE HALO WAS REMOVED. THERE WAS NO SIGN OF INFECTION. TWO DAYS AFTER REMOVAL, PATIENT HAS A SEIZURE. MR SCAN REVEALED A TRAUMATIC SWOLLEN CORTEX UNDER THE RIGHT DORSAL SKULL PIN TRACK AS WELL AS SMALL SUBARACHNOID HEMATOMA. PATIENT WAS TREATED WITH ANTIEPILEPTIC MEDICATION AND THERE WAS NO FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREMER SKULL PIN TEMP, FIXATION DEVICE HBL DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention