BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_OSTEOSYNTHESIS_PRODUCT

    MDR report key: 4202062 · Received October 27, 2014

    Report

    Report Number
    0008031020-2014-00499
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    June 28, 2014
    Report Date
    September 10, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED INCIDENT COULD NOT BE CONFIRMED, SINCE NO FURTHER INFORMATION IS AVAILABLE AND THE DEVICE IS NOT RETURNED FOR EVALUATION. THIS CASE WAS PRESENTED AT THE (B)(6) 2014, NO FURTHER INFORMATION WAS AVAILABLE. DUE TO LACK OF DETAILS IN THE INFORMATION PROVIDED IT IS DIFFICULT TO MAKE ANY CONCLUSIONS ON WHAT HAS CAUSED THE NON-UNION OF THE FRACTURE. THE USE OF THE IMPLANT IS VERY WELL DOCUMENTED IN SCIENTIFIC ARTICLES AND HAS SHOWN VERY GOOD RESULTS IN ITS INTENDED USE. NON-UNION IS LIKELY TO BE CLINICAL OR PATIENT RELATED RATHER THAN IMPLANT CORRELATED. IN THE INSTRUCTIONS FOR USE, V15014 REV B NON ACTIVE IMPLANT ELOS MEDICAL IFU IS STATED FOLLOWING: IN MANY INSTANCES, ADVERSE RESULTS MAY BE CLINICALLY RELATED RATHER THAN DEVICE RELATED. THE FOLLOWING ARE THE MOST FREQUENT ADVERSE EFFECTS INVOLVING THE USE OF INTERNAL FRACTURE FIXATION DEVICES: DELAYED UNION OR NON-UNION OF THE FRACTURE SITE. [¿] CONDITIONS ATTRIBUTABLE TO NON-UNION, OSTEOPOROSIS, OSTEOMALACIA, DIABETES, INHIBITED REVASCULARIZATION AND POOR BONE FORMATION CAN CAUSE LOOSENING, BENDING, CRACKING, FRACTURE OF THE DEVICE OR PREMATURE LOSS OF RIGID FIXATION WITH THE BONE.¿ [¿] AVASCULAR NECROSIS.¿ [ORIGINAL STATEMENT]. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE AND X-RAYS MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED

    Description of Event or Problem · 1

    AFTER HANSSON PIN SURGERY, FRACTURE PART BECAME NONUNION. THIS CASE WAS PRESENTED AT THE MEETING OF (B)(6) ON (B)(6) 2014. IT IS THE FIRST CASE OF FOUR CASES.

    Description of Event or Problem · 1

    AFTER HANSSON PIN SURGERY, FRACTURE PART BECAME NONUNION. THIS CASE WAS PRESENTED AT THE MEETING OF (B)(6) SOCIETY FOR FRACTURE REPAIR ON (B)(6) 2014. IT IS THE FIRST CASE OF FOUR CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684851 UNKNOWN_OSTEOSYNTHESIS_PRODUCT IMPLANT LXH STRYKER TRAUMA SELZACH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention