MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: NUVASIVE COROENT THORACOLUMBAR SYSTEM,; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6081228
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fractured interbody was received and the complaint was confirmed.Note the inserter was not returned for evaluation.Examination of the device found the cage was fractured into five pieces right at the threaded inserter attachment feature consistent with excessive off angled force.The insert and twist procedure required for implantation of the large mp cage requires adequate distraction, excessively forcing the implant on the inserter or leaving the inserter too loose during malletting can result in fracture.No definitive root cause can be determined however, implant selection, insufficient space prep/distraction, off-axis impact with the mallet or an attempt to forcibly rotate an over sized implant in the disc space is suggestively the causes or contributors to the event.No additional investigation can be completed.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.While proper selection can minimize risks." ".All implants should be used only with the appropriately designated instrument." ".Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage." ".Devices should be inspected for damage prior to implantation.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".
Event or Problem Description
The cage was implanted according to the surgical instructions using the insert and rotate technique.When the cage was rotated to its final position, it broke into several fragments.All fragments have been removed.The patient was then treated with new cages and the case was finalized.

• Brand Name: NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: NUVASIVE COROENT THORACOLUMBAR SYSTEM,
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 15968967
• Report Number: 2031966-2022-00282
• Device Sequence Number: 17371621
• Product Code: MAX
• UDI-Device Identifier: 00887517283887
• UDI-Public: 887517283887
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/12/2022

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: 6081228
• Device Lot Number: NU8832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• 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: 08/30/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERTER
• Patient Sex: Prefer Not To Disclose