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

Model Number	7175024
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was received as no product fault was alleged.No radiographs could be provided confirming the alleged complaint.Review of the reported event identified the combing of nuvasive and another manufactures products and is considered of label usage as results are unknown.No additional investigation required.Label review ".Potential adverse events and complications - 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." ".Compatibility: do not use nuvasive instruments with components of other systems.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system." ".Pre-operative warnings - the method of use for the instruments are to be determined by the user¿s experience and training in surgical procedures." ".Intra-operative warnings - 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.".No device fault alledged.
Event or Problem Description
On (b)(6) 2022 a patient underwent a posterior spinal procedure from l4-l5.During the procedure a competitor bone funnel was inserted into the disc space to insert autologous bone when bleeding was observed.Hemostasis was performed, but blood pressure was low (50/30), so the planned posterior fixation was not performed.The patient was transported to other facility and a stent was placed.The amount of blood loss is unknown.The bleeding was suspected to have occurred anteriorly as there was a possibility the disc was damaged during curettage with the ring curette.The root cause could not be confirmed.The patient is recovering well and posterior fixation is planned to be performed at a later date.

• Brand Name: NUVASIVE GENERAL INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92126
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13367764
• Report Number: 2031966-2022-00020
• Device Sequence Number: 5379377
• Product Code: LHX
• UDI-Device Identifier: 00887517913333
• UDI-Public: 887517913333
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2022

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: 7175024
• 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: 01/06/2022
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female