BEUDAMED
    FDA Adverse Event Summary report: N

    LACTOSORB PLATES AND SCREWS

    MDR report key: 1671191 · Received April 30, 2010

    Report

    Report Number
    1032347-2010-00054
    Date Received
    April 30, 2010
    Report Date
    April 1, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    A RETROSPECTIVE REVIEW OF JOURNAL ARTICLES FROM 1999 TO 2010 WAS PERFORMED ON (B)(4) 2010. DURING REVIEW, DETERMINATION WAS MADE THAT DETAILS IN THE ARTICLE MAY NOT HAVE BEEN REPORTED FOR MEDWATCH FILING. ARTICLE: FIXATION OF ZYGOMATIC FRACTURES WITH A BIODEGRADABLE COPOLYMER OSTEOSYNTHESIS SYSTEM: SHORT AND LONG TERM RESULTS, BY G ENISLIDIS, ET AL. IN THE INTERNATIONAL JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY 2005: 34:19-26. IN A SERIES OF 65 PATIENTS WITH ZYGOMATIC FRACTURES, OPERATED ON FROM (B)(6) 1996 TO (B)(6) 1998; A SHORT TERM COMPLICATION RATE OF 22.8% AND LONG TERM COMPLICATION RATE OF 9.4% WERE RECORDED. LACTOSORB PLATES, PANELS AND SCREWS WERE THE ONLY DEVICES USED FOR OSTEOSYNTHESIS. ALL COMPLICATIONS ASSOCIATED WITH THE BIODEGRADABLE MATERIAL COULD BE CONSIDERED MINOR AND WERE RESOLVED BY THE USE OF MINOR SURGICAL PROCEDURES OR CONSERVATIVE MEASURES. INTRAOPERATIVE COMPLICATIONS WERE INCOMPLETE SCREW INSERTION, SCREW BREAKAGE AND STRIPPING OF THE SCREW HOLES. FIRST, INADEQUATE TAPPING RESULTED IN INABILITY TO FULLY SEAT NINE SCREWS. SECOND, THE INTRAOPERATIVE BREAKAGE OF NINE SCREWS WAS OBSERVED; THE SCREW FAILURES WERE ESTIMATED TO BE MAINLY CAUSED BY INSUFFICIENT PRE-TAPPING AND CONSEQUENTLY EXCESSIVE FRICTION BETWEEN BONE AND SCREW. THIRD, 44 SCREWS WERE REGISTERED AS SPINNERS, MEANING THEY WERE UNABLE TO ENGAGE BONE AND PRESS THE PLATE OR PANEL AGAINST THE BONY SURFACE. IT WAS NOTED THE PRESENCE OF AN EXPERIENCED SURGERY WAS IMPERATIVE FOR SUCCESSFUL COMPLETION OF THE OPERATIVE PROCEDURES. POSTOPERATIVE COMPLICATIONS IN 16 OF 53 PATIENTS (OBSERVATION PERIOD >5 YEARS): 4-DEHISCENCE WITHOUT IMPLANT EXPOSURE, 1-DEHISCENCE WITH IMPLANT EXPOSURE, 2-TEMPORARY SWELLING, 2-MAXILLARY SINUSITIS, 2-HYPERTROPHIC SCAR, 3-TEMPORARY ECTROPION, 5-LONG TERM ECTROPION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSORB PLATES AND SCREWS BONE PLATES AND SCREWS HRS BIOMET MICROFIXATION

    Patients

    Seq Age Sex Outcome Treatment
    1