BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSON

    MDR report key: 18536690 · Received January 18, 2024

    Report

    Report Number
    3011390763-2024-00001
    Event Type
    Injury
    Date Received
    January 18, 2024
    Date of Event
    December 27, 2023
    Report Date
    January 18, 2024
    Manufacturer
    NEXUS SPINE, LLC
    Product Code
    MNI
    UDI-DI
    B6785202330
    PMA / PMN Number
    133287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ORIGINAL SURGERY WHEN THE DEVICES WERE IMPLANTED: (B)(6) 2023 DEVICES EXPLANTED: (B)(6) 2023; DEVICES NOT AVAILABLE AND NOT RETURNED FOR INVESTIGATION. FURTHER ADDITIONAL INFORMATION REPORTED FROM COMPLAINANT: " A 66 YEAR OLD OBESE FEMALE WHO HAD A GRADE 1 SPONDYLOLISTHESIS. SHE UNDERWENT A LAMINECTOMY AND PRESSON PSF WITHOUT INTERBODY. POD #1 XRAYS SHOWED GOOD REDUCTION, ON POD#3 SHE DEVELOPED INCREASING LEG PAIN, AND ON POD#6 SHE WAS READMITTED. MRI SHOWS LARGE L4-L5 DISC HERNIATION WITH SEVERE CENTRAL STENOSIS AND LOSS OF REDUCTION. CT SCAN SHOWS NO FRACTURE, AND IDEAL SCREW TRAJECTORY." CASE REVIEW AND SURGEON INTERVIEW CONDUCTED BY COMPANY REPRESENTATIVE ON 12/28/2023: A REVISION SURGERY WAS PERFORMED BY THE SURGEON YESTERDAY AFTERNOON, 6 DAYS AFTER THE PRIMARY SURGERY, ON A 66 Y/O FEMALE WITH A BMI OF 38. SHE HAD DEVELOPED POST-OP NEUROLOGICAL SYMPTOMS. THE SURGEON DISCOVERED INTRA-OPERATIVELY THAT AN L5 PEDICLE WAS FRACTURED AND THAT THERE WAS A LARGE CENTRAL DISC HERNIATION. ALSO, THE PRESSON HARDWARE HAD NOT FAILED AND WAS FULLY INTACT. HE REMOVED THE PRESSON RODS SO AS INTRODUCE AN INTERBODY DEVICE. HE ALSO REPLACED THE ONE PEDICLE SCREW IN THE FRACTURED PEDICLE WITH A LARGER DIAMETER PRESSON SCREW, GOING UP TO A 8.5MM. HE THEN ADDED NEW PRESSON RODS. THE OLD RODS WILL NOT BE RETURNED. THE SURGEON AND HIS PA EXPRESSED INCREASED CONFIDENCE IN PRESSON AND A NEW APPRECIATION FOR THE NEED TO USE INTERBODY DEVICES. DEVICE REVIEW 1. THE EXPLANTED DEVICES WERE NOT RETURNED TO ALLOW FOR FURTHER EVALUATION. 2. THE PART NUMBERS AND LOT NUMBERS OF THE DEVICES USED IN THE CASE WERE IDENTIFIED BASED ON THE SURGERY INFORMATION FROM THE CASE RECORDS PROVIDED BY THE CUSTOMER SERVICE, AND ARE AS FOLLOWS: SYSTEM PART DESCRIPTION PART NO. UDI-DI NO. LOT NO. QTY PRESSON MIS PEDICLE SCREW 7.5 X 45MM CANNULATED 520233 (B)(4). M96585 3 PRESSON MIS PEDICLE SCREW 7.5 X 40MM CANNULATED 520232 (B)(4). J84871 1 PRESSON FIXED LENGTH COUPLER 20MM 520282 (B)(4). G86140 1 PRESSON FIXED LENGTH COUPLER 18MM 520281 (B)(4) G87677 1 PRESSON LOCKING RIVETS 520864 (B)(4) DHR REVIEW SUMMARY - NO MATERIAL NON-CONFORMANCES, NO MANUFACTURING ERRORS, NOR DISCREPANCIES WITH RESPECT TO MATERIAL TYPE, TREATMENTS, DIMENSIONS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. PARTS MET ACCEPTANCE CRITERIA UPON RELEASE.

    Description of Event or Problem · 0

    PATIENT HOSPITALIZED FOR REMOVAL AND REPLACEMENT OF PEDICLE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713282 PRESSON PEDICLE SCREW SYSTEM MNI NEXUS SPINE, LLC 520233 M96585 B6785202330

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention