MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE® COROENT® THORACOLUMBAR SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	D1658087
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 a patient underwent a transforaminal lumbar interbody fusion procedure from l4 to l5.During the procedure an instrument fractured in the patient while performing a rotational maneuver.The fractured portion of the device was left in the patient and radiographs confirmed that it was totally within the vertebral body.There is no plans for revision as the patient is asymptomatic.
Additional Manufacturer Narrative
No product was returned for evaluation though a radiograph and photos of the device confirmed the complaint.Review of the received information and interview with the surgeon rep identified the surgeon utilized the wrong instrument to perform that rotation maneuver and considered the root cause of the event.The patient is asymptomatic, no revision is planned and the surgeon will continue to monitor the patients status.No additional investigation required.Label review: "do not implant the instruments: complications to the patient may include, but are not limited to: nerve damage, paralysis, pain, or damage to soft tissue, visceral organ, or joints.Dural leak in cases of excessive load application or impingement of close vessels, nerves, and/or organs by slippage or misplacement of the instrument.Bony fracture, especially in the case of deformed spine or weak bone.Infection, if instruments are not properly cleaned and sterilized.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.Pain, discomfort, or abnormal sensations resulting from the presence of the device." "pre-operative warnings: some instruments may be used in conjunction with other nuvasive devices.Refer to the instructions for use for these devices for important labeling information." "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 (b)(4).''.

• Brand Name: NUVASIVE® COROENT® THORACOLUMBAR SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• 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: 12838087
• Report Number: 2031966-2021-00160
• Device Sequence Number: 4638798
• Product Code: MAX
• UDI-Device Identifier: 00887517415967
• UDI-Public: 887517415967
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K170962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/18/2021

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: D1658087
• Device Lot Number: TI1269
• 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: 10/31/2021
• Initial Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• 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
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 75 KG