BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING CALCANEAL PLATE MINI-RIGHT

    MDR report key: 7252933 · Received February 8, 2018

    Report

    Report Number
    2939274-2018-50557
    Event Type
    Injury
    Date Received
    February 8, 2018
    Report Date
    January 20, 2018
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    LXT
    UDI-DI
    10886982167361
    PMA / PMN Number
    K991407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATE OF BIRTH AND WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. DATE OF IMPLANT REPORTED AS APPROXIMATELY 7 YEARS PRIOR TO EXPLANT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW: PART MFG DATE: 20-NOV-2008, PART EXP. DATE: N/A, MANUFACTURING LOCATION: DEPUY SYNTHES ¿ (B)(4): PART NUMBER: 241.618, LOT NUMBER: 6022445: DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO NONCONFORMANCES. THE DHR SHOWS LOT# 6022445 OF LOCKING CALCANEAL PLATE MINI-RIGHT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NONCONFORMANCES OR REWORK NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DHR REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NONCONFORMANCES OR REWORK NOTED. 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 HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2018 DUE TO PATIENT PAIN AND POSSIBLE INFECTION, THERE WAS ALSO DRAINAGE AT THE SURGICAL SITE. A LOCKING CALCANEAL PLATE, 12 LOCKING SCREWS AND ONE CORTICAL SCREW WERE REMOVED. ALL PARTS WERE INTACT, NO MALFUNCTIONS. NO REVISION SURGERY WAS PERFORMED, NO ADDITIONAL X-RAYS WERE TAKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAYS AND THE PATIENT STATUS WAS NOTED AS STABLE. THE ORIGINAL SURGERY WAS FOR AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF A CALCANEUS FRACTURE. THE ORIGINAL SURGERY DATE IS UNKNOWN BUT WAS PERFORMED APPROXIMATELY SEVEN YEARS PRIOR TO REMOVAL. THIS REPORT IS FOR ONE (1) LOCKING CALCANEAL PLATE MINI-RIGHT. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99108 LOCKING CALCANEAL PLATE MINI-RIGHT APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM LXT WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 241.618 6022445 10886982167361

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention