MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE GENERAL INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 05/31/2023

Event Type  Injury  

Manufacturer Narrative

There was no product returned for evaluation as no product malfunction was alleged or identified.Review of the provided information identified a surgical error took place with an unknown drill during a nuvasive procedure and an incidental durotomy took place.The tear was sealed and resolved with no additional patient injuries reported.The root cause of the event is considered to be the result of surgical error and unrelated to nuvasive device functionality.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." "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 (with the potential for cerebrospinal fluid leakage)." "patient education: preoperative instructions to the patient are essential.The patient should be made aware of the potential risks of the surgery." "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." "devices distributed by nuvasive the instructions for use (ifu) of devices distributed by nuvasive are provided either electronically or physically depending on the individual setup; however, ifus can also be obtained upon request (refer to information section below).Where the manufacturer provides electronic instructions for use (eifu), nuvasive provides a link directly to the manufacturer¿s eifu website on its own electronic ifu website: www.Nuvasive.Com/eifu." "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 (b)(4).You may also email: (b)(4) h3 other text : no device problem alleged.

Event Description

During a foraminotomy at c4/5, there was a dural tear during the decompression part of the surgery.The tear was sealed with adherus dual sealant.A valsalva maneuver was performed to ensure it was water tight.No additional issues reported.

• Brand Name: NUVASIVE GENERAL INSTRUMENTS
• Type of Device: 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: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17785387
• MDR Text Key: 323877308
• Report Number: 2031966-2023-00206
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• 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: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN DRILL
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose