BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/6 HOLES/LEFT

    MDR report key: 4111206 · Received September 23, 2014

    Report

    Report Number
    3006126083-2014-10020
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 27, 2014
    Manufacturer
    SYNTHES RARON
    Product Code
    HRS
    PMA / PMN Number
    PK120854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS 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. 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

    IT WAS REPORTED THAT A PATIENT CAME IN FOR REMOVAL OF BROKEN HARDWARE (DATE OF ORIGINAL IMPLANT: ESTIMATED (B)(6) 2013). THE BONE DID NOT HEAL FAST ENOUGH, REPORTED AS "NON-UNION." ON (B)(6) 2014, THE PATIENT UNDERWENT EXPLANT, A BONE GRAFT, AND PLACEMENT OF NEW HARDWARE. THE REMOVAL OF THE BROKEN HARDWARE WAS DIFFICULT AND REQUIRED ADDITIONAL INTERVENTION WHICH EXTENDED THE OPERATIVE TIME TO EQUAL OR GREATER THAN 30 MINUTES. THE BROKEN SCREWS WERE SOME 2.7 VA LOCKING SCREWS, 3.5 VA LOCKING SCREWS, AND A 3.5 LOW PROFILE CORTEX SCREW. INFORMATION ON THE SCREW SIZES IS UNKNOWN, AS THEY ARE BROKEN AND SOME OF THEM ARE JUST THE HEADS OF THE SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT'S OUTCOME IS UNKNOWN. THIS REPORT IS 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589726 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/6 HOLES/LEFT PLATE, FIXATION, BONE HRS SYNTHES RARON 8137127

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention