BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MSP METATARSAL SHORTENING SYSTEM

    MDR report key: 10303346 · Received July 21, 2020

    Report

    Report Number
    3009540749-2020-00016
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    March 14, 2020
    Report Date
    September 28, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K140724
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOWUP REPORT TO 3009540749-2020-00016, SECTIONS WITH NO UPDATES WERE LEFT BLANK AS PER 21CFR803 SEC 803.56 (C). THE NEW INFORMATION OBTAINED AND RECORDED IN THE FOLLOWUP DOES NOT CHANGE THE INITIAL INVESTIGATION RESULTS. NO PRODUCT WAS RETURNED TO NEXTREMITY SOLUTIONS FOR REVIEW. ROOT CAUSE REMAINS UNKNOWN. IF NEW INFORMATION IS OBTAINED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION RESULTS, A FOLLOWUP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THIS REPORT IS A FOLLOWUP TO 3009540749-2020-00016 WHICH WAS SUBMITTED ON 21 JUL 2020. IT WAS REPORTED ON 7 SEP 2020 THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 FOR THE MSP METATARSAL SHORTENING SYSTEM THAT WAS IMPLANTED ON (B)(6) 2020 DUE TO ONE OF THE SCREWS BACKING OUT OF THE MSP PLATE, AS REPORTED IN 3009540749-2020-00016. ALL IMPLANTS HAVE BEEN REMOVED AND REPLACED WITH AN UNKNOWN SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. DEVICE HISTORY RECORDS RELATED TO THE EVENT WERE REVIEWED. THERE WERE NO NON-CONFORMANCES DETECTED THROUGH THE DEVICE HISTORY RECORD REVIEW. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE.

    Description of Event or Problem · 1

    10 WEEKS POST-OP OF A MSP METATARSAL SHORTENING SYSTEM PROCEDURE, THE SURGEON REPORTED ONE OF THE SCREWS IS STARTING TO BACK OUT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PRODUCT REMAINS IMPLANTED AND THE SURGEON IS MONITORING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767137 MSP METATARSAL SHORTENING SYSTEM SCREW HWC NEXTREMITY SOLUTIONS 170217-04

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention