MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	10055445
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 a patient underwent a spinal procedure.On (b)(6) 2022 a revision was completed for reasons unknown where the surgeon attempted to remove the x-connector, but the screw thread was smashed and could not be removed requiring the rods to be removed and replaced.
Additional Manufacturer Narrative
Device was not returned nor were photographs provided to confirm the complaint.It is unknown if removal of the hardware was due to complete fusion.Due to lack of information it could not be determined whether the damage to the locking mechanism took place during the index procedure or removal so no root cause cannot be determined.Though review of similar reported events suggests excessive off-angled force, incomplete rod engagement, insufficient tool engagement, and or excessive torque as possible cause or contributors.No additional investigation can be completed.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.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.Care should be taken to insure that all components are ideally fixated prior to closure.Pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient.Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.Device not returned.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 15229895
• Report Number: 2031966-2022-00148
• Device Sequence Number: 15028968
• Product Code: NKB
• UDI-Device Identifier: 00887517534705
• UDI-Public: 887517534705
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/15/2022

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: 10055445
• Device Lot Number: N277258
• 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: 07/27/2022
• Initial Report FDA Received Date: 08/15/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose