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

Model Number 13550000

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Pain (1994)

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation but ap and lateral radiographs were provided confirming the device failure.The patients was reported to have been compliant with post-op instructions regarding activity restrictions.Root cause could be determined due to a lack of information provided, however review of the reported event and radiographs indicate possible rod reduction, normalization and rod contouring challenges are the possible cause or contributor to the event.No additional investigation can be completed.Label review: "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." "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, pain, discomfort or abnormal sensations due to the presence of the device." "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 bullated 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." "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.".

Event Description

On (b)(6) 2021, a (b)(6) year old patient underwent a posterior fixation procedure on unknown levels of the spine.A few days following the surgery the patient was reported to be experiencing additional pain.On a (b)(6) 2021 it was discovered via radiograph that x2 of the implanted lock screws backed out on the left l3 and l4 side of the construct.On a (b)(6) 2021 a revision occurred where the two backed out lock screws were replaced.During the procedure it was also discovered that the lock screws at l1 and t12 were loose and were sitting proud.These were also replaced during the revision.The patients post op status is currently unknown.(related complaints (b)(4)).

Manufacturer Narrative

The device's were received per rma as well as ap and lateral radiographs confirmed the product complaint.Examination of the explanted devices identified rod interference during lock screw initiation and final tightening indicating insufficient rod contouring and anatomical challenges as causal factors.No additional investigation required.Labeling review: ".Potential adverse events and complications: 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." ".Warnings, cautions and precautions: if healing is delayed, or does not occur, the implant may eventually loosen." ".Patient education: 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." ".Step 4: rod & lock screw insertion after cutting the rod to length and contouring, place the rod into the implants and insert lock screws to provisionally secure the rod.1.The rod holder may be used to assist in placing the rod (fig.13).Use the longitudinal lines to ensure the rod is placed in proper sagittal alignment.To release the rod, depress the button at the center of the proximal ratchet.2.The multi-load lock screw starter can be used to deliver up to eight lock screws when no reduction is required (fig.14).O turn the gray central sleeve counterclockwise to fully retract the distal sleeve.O insert the distal end into the lock screw (5.5 or 6.0 mm, cannulated only), ensuring the silver side of the lock screw is facing up.O once the lock screws have been loaded, turn the central sleeve clockwise to compress the lock screws together.Do not hold onto the central sleeve during lock screw delivery, as this will cause the distal sleeve to retract, preventing adequate compression of the lock screws.O after delivery of each lock screw, rotate the central sleeve clockwise until resistance is felt prior to delivering the next lock screw.Tip: the lock screws on the multi-load lock screw starter must be compressed by the central sleeve after delivery of each lock screw to ensure proper engagement into the tulip.3.If reduction is required, use the lock screw starter to load a single lock screw and deliver down the reducer of choice." ".Warnings, cautions and precautions: care should be taken to insure that all components are ideally fixated prior to closure.All implants should be used only with the appropriately designated instrument (reference surgical technique)." ".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 final-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.New and updated information found in sections: b4, d9, g3, g6, h2, h3, h4, h6, h10.

Event Description

New and updated information listed on h10new and updated information listed on h10.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 12584220
• MDR Text Key: 281927621
• Report Number: 2031966-2021-00139
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517551702
• UDI-Public: 887517551702
• Combination Product (y/n): N
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13550000
• Device Lot Number: N286418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 59