BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7399176 · Received April 5, 2018

    Report

    Report Number
    2939274-2018-51465
    Event Type
    Injury
    Date Received
    April 5, 2018
    Report Date
    March 9, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT HEIGHT REPORTED AS (B)(6). THIS REPORT IS FOR AN UNKNOWN MATRIXRIB SCREW/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANT REPORTED AS UNKNOWN DATE IN (B)(6) 2017, EXACT DATE IS NOT KNOWN 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. 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 USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: UNKNOWN WHEN DEVICE MIGRATED. 510K: THIS REPORT IS FOR AN UNKNOWN SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. ORIGINAL IMPLANT DATE IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. ADDITIONAL 510K# K131548. (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. INVESTIGATION SUMMARY: DHR REVIEW COULD NOT BE CONDUCTED DUE THE INSUFFICIENT INFORMATION¿S. PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE ON FRIDAY (B)(6) 2018 DUE TO LOOSING SCREWS. THE SCREWS WERE DISCOVERED TO BE LOOSENING IN AN X-RAY TAKEN ON AN UNKNOWN DATE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN UNKNOWN AMOUNT OF SCREWS AND A PLATE ON AN UNKNOWN DATE IN (B)(6) 2017. ALL THE SCREWS AND THE PLATE WERE REMOVED DURING THE (B)(6) 2018 PROCEDURE. THIS REPORT INVOLVES 1 DEVICE. REPORTED CONCOMITANT PRODUCT TI MATRIXRIB PRE-CONTOURED PL 18 HOLES FOR LEFT RIBS 8 & 9 (PART NUMBER: 04.501.007, LOT NUMBER: UNKNOWN, QUANTITY: 1). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242777 SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention