BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/6H/RT/135MM-STER

    MDR report key: 8383732 · Received March 1, 2019

    Report

    Report Number
    2939274-2019-56757
    Event Type
    Injury
    Date Received
    March 1, 2019
    Report Date
    February 7, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982034526
    PMA / PMN Number
    K013248
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. EXPIRATION DATE PROVIDED FOR REPORTING. ADDITIONAL INFORMATION PROVIDED FOR REPORTING. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE DEVICE WAS 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.

    Description of Event or Problem · 0

    UPDATE: ALLERGY TESTING WILL NOT BE COMPLETED UNTIL EARLY (B)(6) 2019. IT IS A 4 ¿ 6 STEP PROCESS.

    Additional Manufacturer Narrative · 1

    PATIENT ID: (B)(6). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PHONE NUMBER EXTENSION: (B)(6). PART: 02.112.514S, LOT: H123196: PART MANUFACTURE DATE: JULY 13, 2016. MANUFACTURING LOCATION: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DEVICES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE, THE LOCKING COMPRESSION PLATE, LOCKING SCREW 36MM, LOCKING SCREW 30MM AND VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) WERE IMPLANTED DUE TO RIGHT ANKLE FRACTURE. THE SURGEON ASKED FOR A METAL ALLERGY TEST OF WHAT PARTICULAR PLATE IS MADE OF. THE PATIENT HAD AN ADVERSE REACTION TO THE PLATE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A LCP LOW BEND MEDIAL DSTL TIBIA PLATE. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174363 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/6H/RT/135MM-STER PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.112.514S H123196 10886982034526

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention