BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALLU LOCK C PLATE SIZE 2 LEFT

    MDR report key: 1712246 · Received May 28, 2010

    Report

    Report Number
    9615741-2010-00021
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 28, 2010
    Manufacturer
    NEWDEAL S.A.S.
    Product Code
    HXW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE HALLULOCK PLATE WAS USED TO ACHIEVE INTERNAL FIXATION OF THE LEFT METATARSOPHALANGEAL JOINT (MPJ) DURING ARTHRODESIS SURGERY FOR DEGENERATIVE JOINT DISEASE ON (B)(6) 2009. A REVISION SURGERY WAS DONE FOR NONUNION OF THE ARTHODESIS ON (B)(6) 2009. THE SAME PLATE WAS USED WITH A DIFFERENT ARRANGEMENT OF SCREWS AND A PHALANGEAL SCREW AND BONE MATRIX WERE INTRODUCED. ON (B)(6) 2010, THE PHALANGEAL PLATE SCREW WAS OBSERVED TO BE BACKING OUT. THIS SCREW WAS REMOVED DURING A DOCTOR'S OFFICE VISIT. THE PATIENT HAD SOME PAIN AND SWELLING AT THE SURGICAL SITE. THE PATIENT WAS RESCHEDULED FOR A REVISION SURGERY ON (B)(6) 2010. DURING THIS PROCEDURE, ALL THE SCREWS AND THE PLATE WERE REMOVED. A BONE ALLOGRAFT WITH BONE MATRIX WAS USED IN THE JOINT SPACE. TWO THREADED STEINMAN PINS WERE USED TO IMMOBILIZE THE JOINT. THE PATIENT WAS OBSERVED TO HAVE BEEN NON COMPLIANT WITH POST OPERATIVE NON WEIGHT BEARING INSTRUCTIONS. HE IS NOT OVERWEIGHT. THE INSTITUTION'S CASE REVIEW SUGGESTED THAT A LONGER PLATE MAY HAVE BEEN A PREFERRED CHOICE INITIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALLU LOCK C PLATE SIZE 2 LEFT NA HXW NEWDEAL S.A.S. EE89

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention BONE GRAFTS| QWIX SCREW