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

Model Number 10055445

Device Problem Failure to Disconnect (2541)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 304914083
• Report Number: 2031966-2022-00148
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517534705
• UDI-Public: 887517534705
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose