MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE MODULUS XLIF INTERBODY SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS

Model Number	1775850
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to nuvasive and the complaint was confirmed.Examination of the returned device was completed and the fracture pattern identified was consistent with excessive force fracture.Review of the information received identified the tip fractured during impaction indicating excessive off-angled force as the likely cause.Manufacturing review identified lot ms5491 was released to the field on december 1, 2018 as part of a loaner set that is subjected to handling and repeated sterilization cycles after distribution into the field.Wear and damage can accumulate over time.The root cause was determined to be component failure resulting from off-angled excessive force applied during impaction and or aged wear excessive use fatigue.The unretrieved tip in the patient is not a concern for migration as the photographs confirmed it was firmly secured in the interbody.No additional investigation required.Labeling review: "residual risks and potential side effects as with any major surgical procedures, there are risks involved in orthopedic surgery.Cleaning and sterilization failures, sterile barrier compromise, corrosion, and unretrieved instrument fragments which may cause or contribute to infections, fever, wound dehiscence, immunological response and immunological, systemic, or allergic reactions.In some instances, treatment of these events may require surgical intervention including revision surgery." ".Patient education preoperative instructions to the patient are essential.The patient should be made aware of the potential risks of the surgery." ".Do not implant the instruments complications to the patient may include, but are not limited to: breakage of the device, which could make necessary removal difficult or sometimes impossible, with possible consequences of late infection and migration.Breakage could cause injury to the patient." ".Pre-operative warnings the method of use for the instruments are to be determined by the user¿s experience and training in surgical procedures.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 devices and injury to the patient." ".Intra-operative warnings the physician should take precautions against putting undue stress on the spinal area with instruments.Any surgical technique should be carefully followed.It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the patient.Over-bending, notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.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." 9004421-en w-2022-12.
Event or Problem Description
On (b)(6) 2024 during an extreme lateral interbody fusion at l3/5 during the cage insertion at l3/4 the inserter threads snapped.The threads could not be retrieved and were left inside the cage in-situ.No patient injuries were reported.

• Brand Name: NUVASIVE MODULUS XLIF INTERBODY SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 18812728
• Report Number: 2031966-2024-00070
• Device Sequence Number: 20909964
• Product Code: LXH
• UDI-Device Identifier: 00887517913425
• UDI-Public: 887517913425
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1775850
• Device Lot Number: MS5491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN MODULUS INTERBODY
• Patient Age: 73 YR
• Patient Sex: Prefer Not To Disclose