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

Model Number 13600000

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

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

Event Date 12/04/2021

Event Type  malfunction  

Event Description

It was reported that the patient underwent an initial ten (10) level posterior fixation procedure.Subsequently, post operative radiographs identified backing out the lock screw from the inferior right construct approximately six (6) weeks later.A loss of correction in the patient's alignment and movement in the ipsilateral fixation rod was also identified.The patient underwent a revision procedure to remove and replace the affected lock screw and associated pedicle screw approximately two (2) months after the initial procedure.No additional patient consequences were reported.

Manufacturer Narrative

The complainant has indicated that the product is in process of being returned to nuvasive for analysis.Once the investigation has been completed, a supplemental report will be filed accordingly.There are warnings in the product labeling that this type of event can occur: "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.".

Manufacturer Narrative

The complainant has indicated that the product is in process of being returned to nuvasive for analysis.Once the investigation has been completed, a supplemental report will be filed accordingly.There are warnings in the product labeling that this type of event can occur: "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.".

Event Description

It was reported that the patient underwent an initial ten (10) level posterior fixation procedure.Subsequently, post operative radiographs identified backing out the lock screw from the inferior right construct approximately six (6) weeks later.A loss of correction in the patient's alignment and movement in the ipsilateral fixation rod was also identified.The patient underwent a revision procedure to remove and replace the affected lock screw and associated pedicle screw approximately two (2) months after the initial procedure.No additional patient consequences were reported.

Manufacturer Narrative

The device was received by nuvasive on (b)(6), 2022 along with radiographs provided and the complaint was confirmed.The patient postoperative physical activity is unknown.Review of the provided radiographs could not confirm the lock screw back out, though it was confirmed that the caudle right screw tulip appears to be nearly off the end of the rod.Examination of the inferior surface of the lock screw found no expected contact markings to confirm 90 in/lb final torque off was met.360 degree rotational edge scraping identified and consistent with rod contact during lock screw placement as well as back out.No additional investigation required.The root cause of the issue is considered a procedural error related to incomplete lock screw final tightening and or incomplete rod normalization and interference, which can be the consequence of surgical technique but may be the result of anatomical characteristics of the patient.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"."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"."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".

Event Description

On (b)(6) 2021 a patient underwent a ten level posterior fixation procedure.On (b)(6), 2021 during a routine follow up radiographs identified rod length did not look the same as post op radiographs as well as loss of correction (increased tilt) at the bottom right set screw of the construct.(bottom right set screw) on (b)(6), 2021 a revision procedure was conducted where the most caudal pedicle screw on the right side and lock screw were replaced.Patient was asymptomatic.

• 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: 13287171
• MDR Text Key: 285334391
• Report Number: 2031966-2022-00012
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517551719
• UDI-Public: 887517551719
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13600000
• Device Catalogue Number: N/A
• Device Lot Number: N299429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2021
• 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-O SCREW PART # 13046545
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose