MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE X-CORE(R) EXPANDABLE VBR SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	6790153
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was not returned for evaluation, photos provided could not confirm the event.No radiographs could be provided to confirm the event.Review of the reported event identified the implant was forcibly hammered into the disc space while utilizing the counter torque.The interbody vertebral replacement device is not designed to be hammered into place.Rather the disc space is required to be fully distracted.The root cause of the event is the result of implant selection and excessive force.The patient is reported to be recovering well post revision.No additional investigation required.Labeling 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." ".Warnings, cautions and precautions.The subject device is intended for use only as indicated.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant." ".Compatibility: do not use x-core expandable vbr system and the x-core mini cervical expandable vbr system with components of other systems.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system." ".Pre-operative warnings.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Measuring core height.Use the x-core 2 expandable vbr height caliper to measure the defect height.Place caliper tips within the void opening, confirming each tip is seated flush onto the superior and inferior endplates (fig.48).Under no distraction, obtain the reading of the defect height as indicated on either the top or side of the measuring device.If additional distraction is required, utilize the x-core 2 expandable vbr distractor to do so (fig.49).This instrument will not provide height reading but will help to distract the disc space.9500968c.".
Event or Problem Description
A patient underwent a corpectomy procedure where the l2 vertebral body was being replaced.During the procedure the vertebral implant was two large for the space and was forcibly hammered into place.On (b)(6) 2021 a hospital nurse contacted the involved rep to inform then a portion of the counter torque instrument was missing from the device and post operative images confirmed that missing portion was left in patient.On (b)(6) 2021 a revision procedure occurred and the retrieved fragment was removed from the patient.

• Brand Name: NUVASIVE X-CORE(R) EXPANDABLE VBR SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11711968
• Report Number: 2031966-2021-00056
• Device Sequence Number: 3444668
• Product Code: MQP
• UDI-Device Identifier: 00887517360854
• UDI-Public: 887517360854
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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: 6790153
• Device Lot Number: EM1972
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR