MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE 4.5-5.0 SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number SEE H10

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

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

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

No device was returned and no radiographs could be provided confirming the alleged complaint.The patient post op activity levels are unknown and it is unknown whether the patient had achieved fusion.While the root cause of the issue is unknown though the patients post operative physical activity, implant selection and hole preparation are believed to be a possible contributing factor.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)¿" ".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." ".These devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.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." ".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." (b)(4).

Event Description

It was reported that on (b)(6) 2023 a revision of a previous posterior fixation procedure occurred to address the pull out of two vertebral screws at the t3 and t4 levels.During the revision hooks were added and the construct was extended to t2.The patients bone quality or whether the experienced any falls or accidents couldn't be determined.It is unknown when the index procedure occurred, how the failure was discovered or if there were any adverse consequences tot patient as a result of the issue.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: it is unknown which screw was associated with the reported event: [pn 14545025 / ln jp18019 / udi (b)(4)], [pn 14545030 / ln jp18022 / udi (b)(4)], [pn 14514527 / ln jp13389 / udi (b)(4)], or [pn 14544525 / ln jp18013 / udi (b)(4)] d6a: (b)(6) 2019 h4: (b)(6) 2018, (b)(6) 2019, (b)(6) 2017, or (b)(6) 2019 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique.A review of device manufacturing records was performed and no discrepancies relevant to the reported event were found.The surgeon reported that he did not believe the screw pullouts were related to the screw system; but rather was likely a result of the poor bone quality of the patient.The root cause of the issue was unable to be determined with the information provided; however is likely due to patient bone quality.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.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: these devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.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." ".Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw." ".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." ".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." ".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." 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 the patient underwent an initial posterior fixation procedure at t3 to t5 on the right, t4 to t5 on the left, and l4 to l5 bilaterally, with the implantation of adjustable growing rods.It was noted the rods were changed two (2) years and seven (7) months later.Subsequently, approximately 17 months later, a revision of the posterior fixation construct was performed to address the pull-out of two vertebral screws at the t3 and t4 levels.During the revision, hooks were added and the construct was extended to t2.The patient was confirmed to have reduced bone quality and no reported history of falls or other traumatic accidents.The patient was reported to have had no adverse consequences as a result of the issue and is doing well post revision.No additional information was available.Report 2 of 2.

• Brand Name: NUVASIVE RELINE 4.5-5.0 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: geoffry ganon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17731268
• MDR Text Key: 323210934
• Report Number: 2031966-2023-00194
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170126
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• 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
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2023
• 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 Outcome(s): Hospitalization
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 33 KG