BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM VA-LCP X-ARTICLR PROXIMAL ULNA PL 8H/RT/157MM

    MDR report key: 7155176 · Received December 29, 2017

    Report

    Report Number
    2939274-2017-50500
    Event Type
    Injury
    Date Received
    December 29, 2017
    Report Date
    November 30, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982029423
    PMA / PMN Number
    K120070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. DATE INFECTION BEGAN IS NOT KNOWN. DATE OF IMPLANT REPORTED AS APPROXIMATELY 6 MONTHS PRIOR TO REMOVAL. 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

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART# 02.107.408, LOT# 6924100, PART MFG DATE: 20 APRIL 2012, MFG LOCATION: (B)(4) SYNTHES, PART EXPIRATION DATE: N/A , NONCONFORMANCES NOTED: N/A. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 2.7MM/3.5MM VA-LCP X-ARTICULAR PROXIMAL ULNA PLATE 8H/RT/157MM PRODUCT 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. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NONCONFORMANCE NOTED. THIS RAW MATERIAL 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. 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. 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 PATIENT WAS IMPLANTED WITH A 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) EXTRA-ARTICULAR PROXIMAL ULNA PLATE APPROXIMATELY 6 MONTHS PRIOR TO REMOVAL. PATIENT PRESENTED WITH PUS DRAINAGE FROM THE INCISION AND WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE SURGEON REMOVED THE VA LCP EXTRA-ARTICULAR PROXIMAL ULNA PLATE, THREE (3) 3.5MM CORTICAL SCREWS, TWO (2) 3.5MM LOCKING SCREWS, AND SIX (6) 2.7MM VA LOCKING SCREWS. PATIENT WAS REVISED TO ANTIBIOTIC BEADS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934357 2.7MM/3.5MM VA-LCP X-ARTICLR PROXIMAL ULNA PL 8H/RT/157MM PLATE, FIXATION, BONE HRS WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 02.107.408 6924100 10886982029423

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR