BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE, MP, 4 HOLE, MEDIUM BAR

    MDR report key: 8292858 · Received January 31, 2019

    Report

    Report Number
    0008010177-2019-00003
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    January 4, 2019
    Report Date
    May 6, 2020
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS FOUND IN THAT HOSPITAL RECORDS SHOW THE REPORTED PLATES USED ON THE LEFT AND RIGHT MANDIBULAR ANGLE FRACTURES WERE 55-08203 (BONE PLATE, MP, 4 HOLE, MEDIUM BAR). THE SPECIFIC PRODUCT INVOLVED WAS PREVIOUSLY UNKNOWN.

    Additional Manufacturer Narrative · 0

    IN THE PROVIDED X-RAY IT APPEARS THAT TWO MINI PLATES HAVE BEEN USED TO FIXATE LATERAL MANDIBULAR ANGLE FRACTURES. THE LEFT MANDIBULAR IMPLANT IS BROKEN. THE EVENT ¿POSTOPERATIVE PLATE BREAKAGE¿ COULD BE CONFIRMED. HOWEVER, THE USE OF MINI PLATES FOR MANDIBULAR ANGLE FRACTURES IS CONSIDERED OFF-LABEL USE. THIS COMPLAINT HAS BEEN RAISED AS A RESULT OF A LEGAL CLAIM. ADDITIONAL INFORMATION HAS BEEN REQUESTED SEVERAL TIMES, HOWEVER, FURTHER DATA REGARDING THE EVENT COULD NOT BE PROVIDED. THE BROKEN PLATE IN THE PROVIDED IMAGE WAS COMPARED TO SIMILAR PLATES OF THE UNIVERSAL 2 PORTFOLIO, NAMELY THE MP MINI PLATES, AS WELL AS, FRACTURE PLATES. THE COMPARISON HAS SHOWED THAT THE REPORTED PLATE IS MOSTLY LIKELY ONE OF THE FOLLOWING CATALOG NUMBERS: MINI PLATES 1.0 MM PROFILE HEIGHT, 4 HOLES, STERILE AND NON-STERILE - 55-10505 AND 11-10505 MP MINI PLATES 1.0 MM PROFILE HEIGHT, 4 HOLES, STERILE AND NON-STERILE - 55-08203, 01-08203 AND 11-08203. FURTHERMORE, THIS CASE WAS PRESENTED TO STRYKER¿S MEDICAL EXPERT. HE STATED THAT ¿(¿) MINIPLATES ARE NOT INDICATED FOR MANDIBLE ANGLE FRACTURES. (¿).¿ IN THE RELATED BROCHURE, LEIBINGER UNIVERSAL 2 REFERENCE GUIDE (90-01423, E4010, 2010), IT IS ALSO STATED THAT THE 2.0 MM MP MINI PLATES, AS WELL AS, THE 2.0 MM MINI PLATES ARE NOT INDICATED TO BE USED FOR MANDIBULAR ANGLE FRACTURES. BASED ON THE PERFORMED INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION NOR ANY SYSTEMATIC DESIGN, MATERIAL, OR MANUFACTURING RELATED ISSUE. THEREFORE, NO FURTHER CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THAT TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND. SHOULD THE DEVICE BE RETURNED OR FURTHER INFORMATION IS RECEIVED THE INVESTIGATION WILL BE RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER COMPLETION OF A SURGICAL PROCEDURE ON A JAW THAT THE IMPLANT ALLEGEDLY FAILED TO PERFORM AS INTENDED, SO A REVISION SURGERY WAS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER COMPLETION OF A SURGICAL PROCEDURE ON A JAW THAT THE IMPLANT ALLEGEDLY FAILED TO PERFORM AS INTENDED, SO A REVISION SURGERY WAS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER COMPLETION OF A SURGICAL PROCEDURE ON A JAW THAT THE IMPLANT ALLEGEDLY FAILED TO PERFORM AS INTENDED, SO A REVISION SURGERY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85076 BONE PLATE, MP, 4 HOLE, MEDIUM BAR IMPLANT JEY STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1