BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE ANCHORAGE MTP / CROSS PLATE - RIGHT

    MDR report key: 3160798 · Received June 11, 2013

    Report

    Report Number
    0008031020-2013-00180
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 20, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K083447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE PLATE BROKE COULD BE CONFIRMED BY PROVIDED X-RAYS. X-RAYS WERE PROVIDED AS WELL AS PATIENT INFORMATION. THE PATIENT IS (B)(6) WEIGHT FOR ((B)(6)). THE PATIENT IS OBESE. THE PATIENT STARTED TO WALK WITHOUT OFF LOAD SHOES AFTER 5 WEEKS. THIS IS KNOWN THAT BONE GENERALLY TAKES 6 TO 8 WEEKS TO HEAL TO A SIGNIFICANT DEGREE. THE FOOT AND ANKLE SURGEON WILL DETERMINE WHEN THE PATIENT IS READY TO BEAR WEIGHT ON THE AREA. THIS WILL DEPEND ON THE LOCATION AND SEVERITY OF THE FRACTURE, THE TYPE OF SURGICAL PROCEDURE PERFORMED, AND OTHER CONSIDERATIONS. X-RAYS WERE ALSO ANALYZED BY OUR CLINICAL EXPERT. HE STATED: IN CONCLUSION, THE IMPLANT FAILURE HAS BEEN CAUSED IN ALL PROBABILITY BY WRONG (TOO DISTAL) POSITIONING OF THE PLATE IN COMBINATION WITH TOO HIGH POSTOPERATIVE DYNAMIC LOADING OF THE PLATE PRIOR TO SUFFICIENT BONE CONSOLIDATION RESULTING IN FATIGUE FRACTURE OF THE PLATE. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. BASED ON INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED BREAKAGE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE BREAKAGE WAS CAUSED BY OVERLOADING (PATIENT OBESE WITH LOAD AFTER ONLY 5 WEEKS POST OPERATIVELY) IN COMBINATION WITH WRONG (TOO DISTAL) POSITIONING OF THE PLATE. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. IF THE DEVICE BECOMES AVAILABLE, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    DR. HAD MENTIONED THAT THE MPJ PLATE HE USED ON A PATIENT ON (B)(6), HAD BROKEN WHEN PATIENT CAME INTO HIS OFFICE ON (B)(6).

    Description of Event or Problem · 1

    DR. HAD MENTIONED THAT THE MPJ PLATE HE USED ON A PATIENT ON (B)(6) HAD BROKEN WHEN PATIENT CAME INTO HIS OFFICE ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263377 PLATE ANCHORAGE MTP / CROSS PLATE - RIGHT IMPLANT HRS STRYKER OSTEOSYNTHESIS-SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention