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

Model Number SEE H10

Device Problems Expulsion (2933); Osseointegration Problem (3003); Migration (4003)

Patient Problem Paraplegia (2448)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

It is unknown which screw malfunctioned.Model number: 16026550, 16027545, or 16027550; unique identifier (udi) number: (b)(4).Intra-operative radiographs were provided; however, the reported screw pull out and loss of stability could not be identified or confirmed during review of the radiographs.No device was returned to nuvasive for evaluation.It was noted that the patient had poor bone quality, potentially contributing to the screw pull out.Operative notes were not provided for review of usage/technique.A definitive root cause was unable to be determined with the information provided, however may be related to the surgical technique used or patient condition.Labeling review: "contraindications: contraindications include, but are not limited to: patients with inadequate bone stock or quality." "potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity." "warnings, cautions and precautions: 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.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw." "pre-operative warnings: only patients that meet the criteria described in the indications should be selected.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

It was reported that a patient experienced post-operative, lower limb paraplegia after undergoing a revision surgery.The revision surgery was performed to address non-nuvasive fractured rods around the t9 level, which had resulted in patient kyphosis, with a plan to add stabilization with a 4-rod construct.Neuro-monitoring, including monitoring of motor evoked potentials (mep) and electromyography, was performed during the procedure.During the revision, an osteotomy was performed at t9 with a temporary rod placed on one side and affixed utilizing reline screws at t7 and t10.During the osteotomy, lower limb meps started to decrease.Also during the osteotomy, the screws affixing the temporary rod pulled out of the bone, which reportedly may have been related to poor patient bone quality.Approximately one hour after starting the osteotomy, all meps were lost in the lower limbs.The osteotomy was completed and the planned 4-rod construct was successfully implanted.However, the patient woke up with t9 paraplegia with one sensory nerve returning to the lower limbs later in the same day.The surgeon believes the paraplegia was caused by the loss of stability and bone purchase during the osteotomy.No additional information is available.Report 2 of 2.

Manufacturer Narrative

No devices were returned to nuvasive for evaluation and the provided radiographs failed to confirm the reported event.Patient reportedly has poor bone quality.It is unknown if surgeon utilized the existing screw holes from revised screws or created new pilot holes.Review of the provided radiographs and event report identified the patient had previously underwent several spinal procedures related to a severely kyphotic spine and continued pathology.The root cause of the event appears to be the result of patient related factors as the force required to correct anatomical alignment exceeded the capacity of bone quality.No additional investigation can be completed.Related labeling review: ".Contraindications: contraindications include, but are not limited to: 5.Patients with inadequate bone stock or quality.6.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: spinal cord or peripheral nerves; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity.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, fracture of the vertebra, neurological, vascular or visceral injury, decrease in bone density due to stress shielding, nerve damage due to surgical trauma, paralysis." ".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." ".The safety and effectiveness of this device has not been established for use as part of a growing rod construct.This device is only intended to be used when definitive fusion is being performed at all instrumented levels.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." ".All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw." ".Pre-operative warnings: patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." 9401879-en.

Event Description

Corrected information listed on section h10.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 15442657
• MDR Text Key: 300123598
• Report Number: 2031966-2022-00185
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143684
• 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,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEE H10
• 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
• Date Manufacturer Received: 08/22/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: RELINE LOCK SCREW; RELINE MAS SCREW; RELINE TI ROD; RELINE TI ROD
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female