MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE TRAVERSE PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	7820050
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial corpectomy procedure with plate fixation at l2.Subsequently, it was reported that the patient suffered a fall resulting in migration of the plate component.The patient underwent a revision procedure approximately four (4) weeks later to remove the plate construct.The procedure was completed without replacement of the plate fixation components, only the corpectomy cage was left in place.It was noted that the patient experienced a car accident approximately 30 years prior, resulting in several problems including unilateral weakness.No further patient impact was reported.No additional information was available.
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique.It was reported that the patient suffered a fall; however, information regarding the cause or nature of the fall was not provided although it was reported the patient suffered from unilateral weakness as a result of a previous car accident.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided; however, the patient's reported fall was likely the primary contributing factor to the reported migration.Labeling review: ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation, nonunion or delayed union." ".Warnings, cautions and precautions: correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone." ".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.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NUVASIVE TRAVERSE PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 17111424
• Report Number: 2031966-2023-00126
• Device Sequence Number: 2250188
• Product Code: KWQ
• UDI-Device Identifier: 00887517152954
• UDI-Public: 887517152954
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 06/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7820050
• Device Catalogue Number: N/A
• 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: 05/18/2023
• Initial Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRAVERSE SCREW, QTY4; X-CORE IMPLANT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female