MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE X-CORE EXPANDABLE VBR SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	7180033A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a spinal procedure at least one of the two cores was distracted ex-situ, then implanted and could not be distracted in-situ.There was no reported adverse impact to patient or case.
Additional Manufacturer Narrative
No device was returned and no images were provided therefore the complaint cannot be confirmed.Due to a lack of information no root cause could be determined.Review of the reported event and other similar events found it to be consistent with known failure mode where the inserter is attached and turned backwards past the starting point with force, or the core is expanded then retracted with force damaging the device and disallowing further expansion.No patient injury was reported.No additional investigation can be completed at this time.Should more information become available an addition report will be filed.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery." "warnings, cautions and precautions.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." "method of use please refer to the surgical technique for this device." "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 +1-800-475-9131.You may also email: info@nuvasive.Com." (b)(4).
Additional Manufacturer Narrative
The device was received by nuvasive but the complaint was not confirmed.No inserter was returned for evaluation.Examination found the device fully reduced and in the neutral position with minor contact marking and gear sleeve teeth.The lock screw weld was broken but the lock screw was in a neutral position.A standard 7185100 inserter was attached, and the device distracted and retracted as designed, no failure was identified or recreated.Review of the reported event suggests incomplete inserter attachment, improper activation rotation or physical obstruction.The root cause, although unknown, is most likely an inadvertent user error.No further investigation can be completed no problem was identified or recreated.Manufacturing review: review of the device history record notes no material non-conformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: "warnings, cautions and precautions the subject device is intended for use only as indicated.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant." ".All components should be final tightened per the specifications in the surgical technique.Implants should not be tightened past the locking point, as damage to the implant may occur.To help ensure proper inserter/implant engagement, the inserter¿s-colored distal tip must face up toward the like-colored spinning sleeve of the implant." "single use/do not re-use: reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury.Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure, material degradation, potential leachable, and transmission of infectious agents." "method of use please refer to the surgical technique for this device." "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).".Once the core is either in its fully compressed or fully expanded state, do not continue to rotate the teardrop handle.Over-expanding or over compressing may result in implant stripping." (b)(4).
Event or Problem Description
New or updated information listed on section h10.

• Brand Name: NUVASIVE X-CORE EXPANDABLE VBR SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17838543
• Report Number: 2031966-2023-00211
• Device Sequence Number: 7695463
• Product Code: MQP
• UDI-Device Identifier: 00887517365828
• UDI-Public: 887517365828
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193506
• 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): 10/23/2023

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: 7180033A
• Device Lot Number: PD0672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 63 KG