BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE EXTREME LATERAL LUMBAR IMPLANT INSERTER

    MDR report key: 16118212 · Received January 6, 2023

    Report

    Report Number
    2031966-2023-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Report Date
    April 13, 2023
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MAX
    UDI-DI
    00887517383532
    PMA / PMN Number
    K161230
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH REPORT # 2031966 - 2023 - 00001 WAS INADVERTENTLY SUBMITTED. AFTER A REVIEW OF THE REPORTED EVENT AND ADDITIONAL INFORMATION RECEIVED, IT HAS BEEN DETERMINED THAT THERE NO INDICATION OF AN ADVERSE REACTION, DEATH OR SERIOUS INJURY, OR THE NEED FOR INTERVENTION TO PREVENT DEATH OR SERIOUS INJURY. FURTHER, DEATH OR SERIOUS INJURY IS UNLIKELY SHOULD THIS OR A SIMILAR EVENT RECUR AND UNRETRIEVED FRAGMENT WAS LEFT IN THE PATIENT. NO REPORTING IS REQUIRED.

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED TO NUVASIVE FOR EVALUATION; THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF A PHOTOGRAPH OF THE FRACTURED INSERTER. NO OPERATIVE NOTES AND/OR RADIOGRAPH IMAGES WERE PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED. LABELING REVIEW: "THE INSTRUMENTS SHOULD BE TREATED AS ANY PRECISION INSTRUMENT AND SHOULD BE CAREFULLY PLACED ON TRAYS, CLEANED AFTER EACH USE, AND STORED, ACCORDING TO GENERALLY ACCEPTED HOSPITAL METHODS AND PRACTICES. THE INSTRUMENTS SHOULD BE CAREFULLY EXAMINED PRIOR TO USE FOR FUNCTIONALITY, EXCESSIVE WEAR, OR DAMAGE. A DAMAGED INSTRUMENT SHOULD NOT BE USED AS THIS MAY INCREASE THE RISK OF MALFUNCTION AND POTENTIAL PATIENT INJURY." "CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT." "THE PHYSICAL CHARACTERISTICS REQUIRED FOR MANY INSTRUMENTS DO NOT PERMIT THEM TO BE MANUFACTURED FROM IMPLANTABLE MATERIALS. IF ANY BROKEN FRAGMENTS OF INSTRUMENTS REMAIN IN THE BODY OF A PATIENT, THEY COULD CAUSE ALLERGIC REACTIONS OR INFECTIONS. IF AN INSTRUMENT BREAKS IN SURGERY AND FRAGMENTS GO INTO THE PATIENT, THESE PIECES SHOULD BE REMOVED PRIOR TO CLOSURE AND SHOULD NOT BE IMPLANTED." IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    MEDWATCH REPORT # 2031966 - 2023 - 00001 WAS INADVERTENTLY SUBMITTED. AFTER A REVIEW OF THE REPORTED EVENT AND ADDITIONAL INFORMATION RECEIVED, IT HAS BEEN DETERMINED THAT THERE NO INDICATION OF AN ADVERSE REACTION, DEATH OR SERIOUS INJURY, OR THE NEED FOR INTERVENTION TO PREVENT DEATH OR SERIOUS INJURY. FURTHER, DEATH OR SERIOUS INJURY IS UNLIKELY SHOULD THIS OR A SIMILAR EVENT RECUR AND UNRETRIEVED FRAGMENT WAS LEFT IN THE PATIENT. NO REPORTING IS REQUIRED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL EXTREME LATERAL INTERBODY FUSION PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DISTAL TIP OF THE IMPLANT INSERTER FRACTURED. THE FRACTURED PIECE WAS UNABLE TO BE LOCATED AND AS A RESULT, MAY HAVE BEEN RETAINED BY THE PATIENT. IT WAS REPORTED THERE WAS NO INJURY ATTRIBUTED TO THE DEVICE; NO INFORMATION ON ANY FURTHER PATIENT IMPACT WAS PROVIDED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438884 NUVASIVE EXTREME LATERAL LUMBAR IMPLANT INSERTER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE, INC. 6900160 125380-033 00887517383532

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose