BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM VA-LCP EXT MEDL DISTL HUM PL 1H/RT/72MM-SHORT

    MDR report key: 4906000 · Received July 10, 2015

    Report

    Report Number
    2520274-2015-14878
    Event Type
    Injury
    Date Received
    July 10, 2015
    Report Date
    June 24, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK120070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: APRIL 23, 2012. NO NON-CONFORMANCE REPORTS (NCR) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION SUMMARY: THE COMPLAINT CONDITION FOR THE 2.7MM/3.5MM VA-LCP EXTENDED MEDIAL DISTAL HUMERUS PLATE (PART 02.117.601 / LOT 7828110) AND THE 3.5MM LCP HOOK PLATE (PART 02.113.103 / LOT 7960007) WAS LIKELY CAUSED BY IMPROPER PLATE PLACEMENT, IMPLANT MIGRATION, OR UNUSUAL PATIENT ANATOMY. HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. NO PRODUCT ISSUE WAS IDENTIFIED UPON EXAMINATION OF THE THREE RETURNED UNKNOWN SCREWS. THE 2.7MM/3.5MM VA-LCP EXTENDED MEDIAL DISTAL HUMERUS PLATE AND THE 3.5MM LCP HOOK PLATE ARE IMPLANTS ROUTINELY USED IN THE 2.7MM/3.5MM VARIABLE ANGLE LCP ELBOW SYSTEM. THE TWO (2) PLATES WERE RETURNED AND REPORTED TO HAVE BEEN PROMINENT POSTOPERATIVELY. THIS CONDITION IS UNCONFIRMED; HOWEVER, IT IS LIKELY SINCE THE PATIENT REQUESTED THAT THE HARDWARE BE REMOVED. IT IS LIKELY THAT IMPROPER PLATE PLACEMENT, IMPLANT MIGRATION, OR UNUSUAL PATIENT ANATOMY LED TO THE COMPLAINT CONDITION. BOTH PLATES ARE IN CONDITION CONSISTENT WITH INSERTION AND REMOVAL. BOTH PLATES ALSO SHOW DISCOLORATION. THE ASSOCIATED DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DATE OF IMPLANT IS UNKNOWN BUT WAS REPORTED AS APPROXIMATELY ONE AND HALF YEARS PRIOR TO (B)(6) 2015. THIS REPORT IS FOR ONE UNKNOWN HUMERAL PLATE. PART AND LOT NUMBERS WERE NOT PROVIDED BY REPORTER. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    UPDATE: IT WAS REPORTED THAT A 3.5 MM LOCKING COMPRESSION (LCP) 3-HOLE HOOK PLATE WAS INCLUDED WITH THE HARDWARE REMOVED ON (B)(6) 2015 (DUE TO PROMINENCE) AS WELL AS THREE (3) INTACT SCREWS AND FIVE (5) BROKEN SCREW HEADS. IT WAS UNKNOWN IF THE PLATE WAS ASSOCIATED WITH ANY OF THE BROKEN SCREWS. THE BROKEN SCREWS WILL BE REPORTED AND INVESTIGATED WITH AN ASSOCIATED RECORD ((B)(4)). THIS REPORT IS 2 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE IMPLANTATION OF AN UNKNOWN PLATE AND AN UNKNOWN QUANTITY OF UNKNOWN SCREWS TO TREAT A LATERAL HUMERUS FRACTURE. APPROXIMATELY ONE AND A HALF YEARS LATER, ON (B)(6) 2015, THE PATIENT UNDERWENT A PLANNED HARDWARE REMOVAL DUE TO PROMINENT APPEARANCE OF THE HARDWARE. DURING THE PLATE REMOVAL, THE HEADS OF AN UNKNOWN QUANTITY OF 3.5MM CORTICAL SCREWS, POPPED OFF (BROKE OFF) WHILE THE SURGEON WAS REMOVING THE PLATE. THE SHAFTS OF THE SCREWS ARE RETAINED IN THE PATIENT¿S BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO FURTHER PATIENT HARM TO THE PATIENT. THIS COMPLAINT ADDRESSES THE NEED FOR REVISION SURGERY DUE TO PROMINENCE. THE INTRAOPERATIVE SCREW BREAKAGE WAS ADDRESSED AND REPORTED UNDER A SEPARATE, RELATED COMPLAINT ((B)(4)). THIS REPORT IS FOR ONE UNKNOWN HUMERAL PLATE. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449540 2.7MM/3.5MM VA-LCP EXT MEDL DISTL HUM PL 1H/RT/72MM-SHORT PLATE, FIXATION, BONE HRS SYNTHES MEZZOVICO 7828110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention