BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDFUSE PEDICLE SCREW

    MDR report key: 3909319 · Received February 24, 2014

    Report

    Report Number
    3005977257-2014-00001
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    October 14, 2011
    Report Date
    February 10, 2014
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S ACCIDENT (FALL) WAS THE CAUSE OF THE TWO IMPLANT BREAKS. THE PEDFUSE PACKAGE INSERT AVAILABLE THE TIME OF THE COMPLAINT (DOC80001, REV. B) INDICATES IN THE POSTOPERATIVE INSTRUCTIONS THAT "THE PATIENT SHOULD BE WARNED TO AVOID FALLS OR SUDDEN JOLTS IN SPINAL POSITION" AS THIS MAY CAUSE BREAKAGE OF THE TEMPORARY INTERNAL FIXATION DEVICE. A COPY OF THE PACKAGE INSERT EXCERPT IS INCLUDED WITH THIS REPORT. THIS EVENT IS BEING REPORTED UPON REEVALUATION OF A LEGACY COMPLAINT. DUE TO THE LEGACY NATURE OF THE FILE, ADDITIONAL INFORMATION COULD NOT BE OBTAINED TO DETERMINE PATIENT IDENTIFICATION, PRODUCT PART AND LOT NUMBERS AND THE EXACT DATES OF INITIAL AND REVISION SURGERIES. THIS OCCURRENCE IS BEING REPORTED WITH ALL AVAILABLE INFORMATION. DUE TO THE FACT THAT THE EVENT IS BEING REPORTED WITHOUT CAUSE, IT WAS NOT DEEMED NECESSARY TO FURTHER PURSUE INFORMATION SURROUNDING THE EVENT. PEDFUSE PACKAGE INSERT (DOC80001 REV B). PLEASE NOTE THE HIGHLIGHTED INFORMATION ABOUT POSTOPERATIVE DIRECTIONS FOR PATIENT COMPLIANCE. POSTOPERATIVE: THE PHYSICIANS POSTOPERATIVE DIRECTIONS AND WARNINGS TO THE PATIENT, AND THE CORRESPONDING PATIENT COMPLIANCE, ARE EXTREMELY IMPORTANT. DETAILED INSTRUCTIONS ON THE USE AND LIMITATIONS OF THE DEVICE SHOULD BE GIVEN TO THE PATIENT. IF PARTIAL WEIGHT-BEARING IS RECOMMENDED OR REQUIRED PRIOR TO FIRM BONY UNION, THE PATIENT MUST BE WARNED THAT BENDING, LOOSENING AND/OR BREAKAGE OF THE DEVICE(S) ARE COMPLICATIONS WHICH MAY OCCUR AS A RESULT OF EXCESSIVE OR EARLY WEIGHT-BEARING OR MUSCULAR ACTIVITY. THE RISK OF BENDING, LOOSENING, OR BREAKAGE OF A TEMPORARY INTERNAL FIXATION DEVICE DURING POSTOPERATIVE REHABILITATION MAY BE INCREASED IF THE PATIENT IS ACTIVE, OR IF THE PATIENT IS DEBILITATED OR DEMENTED. THE PATIENT SHOULD BE WARNED TO AVOID FALLS OR SUDDEN JOLTS IN SPINAL POSITION. TO ALLOW THE MAXIMUM CHANCES FOR A SUCCESSFUL SURGICAL RESULT, THE PATIENT OR DEVICES SHOULD NOT BE EXPOSED TO MECHANICAL VIBRATIONS OR SHOCK THAT MAY LOOSEN THE DEVICE CONSTRUCT. THE PATIENT SHOULD BE WARNED OF THIS POSSIBILITY AND INSTRUCTED TO LIMIT AND RESTRICT ACTIVITIES, ESPECIALLY LIFTING AND TWISTING MOTIONS AND ANY TYPE OF...

    Description of Event or Problem · 1

    A FULL AUDIT OF ALL REMAINING LEGACY COMPLAINTS SINCE THE IN INCEPTION OF THE COMPANY (2007) WAS CONDUCTED TO ASSURE ANY NON-CONFORMITIES THAT MAY EXIST FROM EARLIER YEARS WERE DISCOVERED AND PROPERLY DOCUMENTED AND ADDRESSED. DURING THE AUDIT THIS REPORTABLE EVENT WAS IDENTIFIED AND IS NOW BEING SUBMITTED. THIS HAD PREVIOUSLY BEEN DEEMED A NON-REPORTABLE EVENT. THIS EVENT WAS TO BE REPORTED WITHIN 30 DAYS OF OCCURRING. A VERY HEAVY, PARALYZED, MALE PATIENT FELL IN THE SITTING POSITION FROM A WHEELCHAIR AND BROKE TWO (2) PREVIOUSLY IMPLANTED 7MM PEDICLE SCREWS. THE SCREWS HAD BEEN IMPLANTED TO REPAIR THE PATIENT'S FRACTURED SACRUM AND FUSION HAD NOT YET OCCURRED. A REVISION SURGERY WAS CONDUCTED TO REPLACE THE BROKEN SCREWS ONE TO TWO WEEKS FOLLOWING THE PATIENT'S FALL. DUE TO THE LEGACY NATURE OF THE COMPLAINT, FURTHER INFORMATION REGARDING THE TIMING OF THE EVENT AND THE DATE(S) OF SURGERY COULD NOT BE OBTAINED. SPECIFIC PATIENT AND PRODUCT INFORMATION COULD ALSO NOT BE LOCATED BECAUSE THE DATE(S) OF SURGERY COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114437 PEDFUSE PEDICLE SCREW PEDICLE SCREW MNI SPINEFRONTIER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention