BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDFUSE

    MDR report key: 6947657 · Received October 13, 2017

    Report

    Report Number
    3005977257-2016-00004
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    February 24, 2016
    Report Date
    August 9, 2017
    Manufacturer
    SPINEFRONTIER, INC
    Product Code
    MNH
    PMA / PMN Number
    K123164
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT REPORTED UNDER MDR 3005977257-2016-00004, STATED THAT A FOLLOW UP X-RAY ON A L5-S1 FUSION SURGERY PATIENT SHOWED THAT THE Ø5-7MM SET SCREW (01-80101, LOT# BE08A ) HAD BACKED OUT OF THE RIGHT INFERIOR (L5) PEDICLE SCREW TULIP (PART#: 02-80081-02 LOT# 8603), A SUB-COMPONENT OF THE PEDICLE SCREW ASSEMBLY (PART#: 01-80169-45R LOT#: AG28). THE SET SCREW WAS FREE FLOATING IN THE SOFT TISSUE. AS A SECOND NOTE, A P-LIFT CAGE USED IN CONJUNCTION WITH THE PEDICLE HAD MIGRATED POSTERIORLY. THIS IS THE SECOND OF 2 OCCURRENCES INVOLVING A SET SCREW BACKING OUT OF A PEDICLE SCREW ASSEMBLY IN THE SAME PATIENT, THE OTHER OCCURRENCE WAS REPORTED UNDER MDR #: 3005977257-2016-00003. BASED ON THE KNOWN FACTORS OF THE SURGICAL EVENT, THE SURGERY WAS PERFORMED IN COMPLIANCE WITH SPINEFRONTIER'S SURGICAL TECHNIQUES AND IFU. THE PEDICLE SCREW ASSEMBLY PART # 01-80169-45R LOT# AG28, INSPECTION DATA SHOWS THAT ALL PARTS OF THE ASSEMBLY CONFORM TO THE DRAWINGS AND ALL PARTS FROM THE CONSTRUCT PASSED FUNCTIONAL FIT CHECKS. THE RISK MANAGEMENT FILES ASSOCIATED WITH THE DEVICE IDENTIFIES THAT THIS FAILURE MODE HAD BEEN ANALYZED AND WAS RATED ALARP WITH AN OCCASIONAL OCCURRENCE, WHICH IS IN LINE WITH WHAT HAS OCCURRED. SPINEFRONTIER MITIGATED THE RISK AS LOW AS REASONABLY POSSIBLE AND ALL OF THE SUPPORTING MITIGATIONS WERE IN PLACE AND SUFFICIENT. IN CONCLUSION, THIS IS AN EVENT THAT MAY HAPPEN WITH AN OCCASIONAL OCCURRENCE AND DOES NOT WARRANT ANY FURTHER ACTION. THE Ø5-7MM SET SCREW (01-80101, LOT# BE08A) THE OTHER COMPONENT WAS REPORTED UNDER MDR #: 3005977257-2016-00006.

    Description of Event or Problem · 1

    A SPINEFRONTIER REPRESENTATIVE STATED THAT A FOLLOW-UP X-RAY REVEALED THAT THE SET SCREW HAD BACKED OUT OF RIGHT INFERIOR (L5) TULIP IN A PATIENT WHO UNDERWENT L5-S1 FUSION REVISION SURGERY. THE SET SCREW WAS FREE FLOATING IN SOFT TISSUE AND THE CAGE HAD MIGRATED POSTERIORLY. THE PATIENTS AGE, WEIGHT, HEIGHT, RELEVANT OR PRE-EXISTING MEDICAL CONDITIONS, MEDICATION, PRE-OPERATIVE X-RAYS/MRI, POST-OPERATIVE X-RAYS/MRI, POST-OPERATIVE ACTIVITIES, AND ANY EVENT THAT MAY HAVE LEAD UP TO THE SET SCREW BACKING OUT WERE REQUESTED BUT ARE UNKNOWN. THIS IS THE SECOND REVISION SURGERY TO REPLACE THE SET SCREW AND THE TULIP. THE FIRST REVISION SURGERY (FOR THE SET SCREW BACKING OUT OF S1) WAS REPORTED UNDER MDR #: 3005977257-2016-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728474 PEDFUSE PEDFUSE MNH SPINEFRONTIER, INC 01-80169-45 AG28

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention