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

Model Number	SEE H10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Great Vessel Perforation (2152)
Date of Event	06/05/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
No product was returned as no product malfunction was alleged.No radiographs or images were provided so the complaint cannot be confirmed.Review of the reported event identified the surgeon allowed the cobb to slip anteriorly and injured the aorta which led to excessive bleeding and death.The root cause of the reported death is considered to be the result of an inadvertent surgical error.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.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: damage to blood vessels.Rarely, some complications may be fatal." "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.Vascular injury." "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." "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.Do not use these instruments for any action for which it was not intended such as hammering, prying, or lifting.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." 9004421-en w-2022-12.
Event or Problem Description
During a spinal procedure at l1/5 after placing a retractor at l4/5, the first level of fixation, the cobb slipped anteriorly while working in the intervertebral space and injured the aorta.Due to excessive bleeding, immediate compression and hemostasis was performed and the patient was transferred to another medical facility.The patient was pronounced dead.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D4: it is unknown which cobb was associated with the reported event: [part #6914424, lot #fd2727206, udi (b)(4)] or [part #6914425, lot #fd3338111, udi (b)(4)] h4: 31jul2012 or 14aug2013.The reported event was unable to be confirmed due to limited information received concerning this event.There was no product failure alleged as apart of the reported event; further, no operative notes, medical records, and/or radiograph images were provided for review of usage/technique.A review of device manufacturing records 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: "¿residual risks and potential side effects: as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: damage to blood vessels.Rarely, some complications may be fatal." ".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.Vascular injury." ".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: the method of use for the instruments are to be determined by the user¿s experience and training in surgical procedures.Do not use these instruments for any action for which it was not intended such as hammering, prying, or lifting.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." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NUVASIVE GENERAL INSTRUMENTS
• 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: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17131550
• Report Number: 2031966-2023-00128
• Device Sequence Number: 18000862
• Product Code: LXH
• UDI-Device Identifier: 00887517392190
• UDI-Public: 887517392190
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SEE H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2012
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 54 YR
• Patient Sex: Male