MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE MODULUS XLIF INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 05/10/2020

Event Type  Injury  

Manufacturer Narrative

This complaint has been created from a clinical study review so no product returned for evaluation and no images were provided so the complaint cannot be confirmed.Review of the provided information identified a surgical error took place causing an incidental durotomy unrelated to nuvasive product functionality and likely of inadvertent instrument contact.No additional information provided and no additional investigation can be completed.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include:.Dural leak." "warnings, cautions and precautions.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.Additional care should be taken at the lower levels of the lumbar spine due to the obstruction of anatomical structures, such as the iliac crest and iliac vessels, surgical access for the subject device at the these levels may not be feasible.Care should be taken to ensure that all components are ideally fixated prior to closure." "pre-operative warnings.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "method of use please refer to the surgical technique for this device." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at +1-800-475-9131.You may also email: info@nuvasive.Com." 9401854-en j-2022-06."residual risks and potential side effects as with any major surgical procedures, there are risks involved in orthopedic surgery.Residual risks to the patient associated with use of general surgical instruments are:.Risks inherent to invasive surgical procedures associated with site access and preparation which cannot be eliminated.These risks include.Dural tear." "residual risks to surgical staff associated with use of general surgical systems are: lacerations, cuts, or abrasions, including due to instrument breakage, slippage, misuse, or mishandling." "pre-operative warnings the method of use for the instruments are to be determined by the user¿s experience and training in surgical procedures.Care should be used during surgical procedures to prevent damage to the device(s) 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." " method of use if there is any doubt or uncertainty concerning the proper use of instruments please contact nuvasive customer service.Any available surgical techniques will be provided upon request.For optimal results, the same type of instruments used for implantation should be used for implant removal." "information to obtain a surgical technique manual or other applicable instructions for use or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at +1-800-475-9131.You may also email: info@nuvasive.Com." 9004421-en w-2022-12.H3 other text : device in-situ.

Event Description

It was reported in a clinical study that a patient underwent a procedure at l3/4 on (b)(6) 2020 and there was a very small incidental durotomy that was unavoidable secondary to the extensive dural adhesions during surgery.It was sewed up with 4 interrupted nurolon sutures.Valsalva showed no significant spinal fluid leakage.No other treatment was reported.No additional injuries reported.

Event Description

Updated or corrected information listed in section h10.

Manufacturer Narrative

This complaint was created from the ams in xlif clinical study complications report review where no product fault was alleged, the devices remain in situ so the complaint could not be confirmed.Review of the reported event identified that this report is not related to a nuvasive device or procedural failure but rather the tear took place while managing the patients identified extensive dural adhesions and considered unavoidable and the result of patient related factors and not a reportable event.No additional investigation is required.Labeling review: "contraindications contraindications include, but are not limited to.6.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." "potential adverse events and complications.Potential risks identified with the use of this system, which may require additional surgery, include.Dural leak." "warnings, cautions and precautions the subject device is intended for use only as indicated.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".Based on fatigue testing results, when using the modulus interbody system, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system." "patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery." "pre-operative warnings 1.Only patients that meet the criteria described in the indications should be selected.2.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at." 9402506-en h-2022-06.Corrected or updated information reported on sections: b4, d1, d2, d6, g3, g4, g6, h2, h6 and h10.

• Brand Name: NUVASIVE MODULUS XLIF INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 18507591
• MDR Text Key: 332870396
• Report Number: 2031966-2024-00022
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose