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

Model Number 13600000

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation currently in process, a request for additional information is still pending.A follow up will be completed when available.H3 other text : device remains in situ.

Event Description

On (b)(6) 2023 a patient underwent a combination posterior spinal fixation and xtreme lateral interbody fusion procedure from t7 to l2.The surgery was completed without issue.Three months later during a routine post op appointment it was reported the patient was experiencing unspecific back pain.Mris/radiographs occurred which discovered the two lock screw at the l2 level had expelled from their seated tulip.On october 23rd 2023 we were informed a revision occurred to reseat and secure the expelled lock screw.During the procedure it was additionally found 4 other set screws were loose at both l1 levels as well as the right t12 and t11.During the revision all loose and expelled lock screws were reused and resecured with torque and counter torque.The revision was completed with no further adverse consequence to the patient.

Manufacturer Narrative

No devices were returned for evaluation as the involved lock screws were re-utilized in the revision surgery and remain in situ, although two lateral radiographs were provided confirming the complaint.No torque handle was returned for evaluation although set history review noted it was tested and passed 19 days prior to use.A definitive root cause for the post operative lock screw back outs could not be determined however, review of the information provided, and similar reports suggests insufficient final torque down and or rod reduction / normalization challenges creating excessive upward force during lock down.No additional investigation can be completed.Manufacturing review: no lot code information was provided for any of the involved lock screws so a complete manufacturing review could not be completed.Although review of ncmr records and similar events notes no non-conformances with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure.Labeling review: "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." "if healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient¿s activity level will dictate the longevity of the implant." "care should be taken to insure that all components are ideally fixated prior to closure." "patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." "post-operative warnings: during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications." "final tightening: all lock screws must be tightened to a torque of 90 in-lbs to effect a secure construct.Tip: the open screw counter-torque handle position can be adjusted in 45° increments by depressing the button at the distal end of the handle and rotating it.Attach the torque t-handle to the final lock screwdriver.Slide the counter-torque over the tulip until the instrument bottoms out.Insert the final lock screwdriver through the counter-torque and seat securely into the lock screw.Turn the torque t-handle clockwise until the breakaway torque is reached.Repeat on each screw." "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.The bulleted portion of the nose of the rod and the faceted portion of the rod (where the inserter locks down on the rod) must extend fully outside of the most inferior or most superior tulip on the construct.The set screw cannot be locked down on this unusable portion of the rod, as this may compromise the stability of the construct.All set screws should be finally tightened with the counter- torque and torque t-handle.Do not final-tighten through compression instruments in the set, as the rod may not be able to normalize to the tulip." "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 leachables, and transmission of infectious agents." "post-operative warnings during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." "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) new or updated information can be found in sections:b1, b4, g3, g6, h2, h6 and h10.

Event Description

New or updated information listed in section h10.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd; san diego 92121
• MDR Report Key: 18165394
• MDR Text Key: 328512484
• Report Number: 2031966-2023-00267
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517551719
• UDI-Public: 887517551719
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13600000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• 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
• Treatment: UNKNOWN RELINE MAS SCREW
• Patient Sex: Female