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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Vertebral Fracture (4520)

Event Date 07/27/2023

Event Type  Injury  

Manufacturer Narrative

No product malfunction was reported so no device was returned and no radiographs were provided therefore the complaint cannot be confirmed.The patient's bone quality is unknown.It is unknown if the patient followed post-operative physical restrictions or suffered a fall.It is unknown if fusion has been completed.Review of the reported event identified the surgeon called out proximal junctional kyphosis and continuation of patient pathology as the root cause of the vertebral fracture which is a known complication of spinal procedures and considered a patient-related factor.No product malfunction was identified and no additional investigation is required.Labeling review: "contraindications include, but are not limited to: patients with inadequate bone stock or quality.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.Potential risks identified with the use of this system, which may require additional surgery, include: nonunion or delayed union, fracture of the vertebra." "warnings, cautions and precautions.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." "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.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.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications." 9400903-en m-2022-12.H3 other text : no device returned, left in-situ.

Event Description

On (b)(6) 2023 the first part of a two part extreme lateral interbody fusion at l3/5 was performed with a spinal cage inserted at l4/5 and a vertebral body replacement implanted at l3.On (b)(6) 2023 the second part was performed with posterior fixation installed at l2/5.On (b)(6) 2023 a revision surgery was conducted due to an l1 fracture due to proximal junction kyphosis (pjk).A vertebral body replacement was inserted at l1 and fixation was extended to t11.

Event Description

N/a.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were corrected: d1, d2, g4 updated: h6, h10 the reported event was unable to be confirmed due to limited information received concerning this event.No device was returned to nuvasive for evaluation; further, no operative notes, medical records, and/or radiograph images were provided for review of usage/technique.A review of manufacturing records was unable to be performed as the part and lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided.Labeling review: "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: fracture of the vertebra." "warnings, cautions and precautions: 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.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." "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.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17491961
• MDR Text Key: 320715294
• Report Number: 2031966-2023-00166
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193506
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2023
• 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
• Treatment: UNKNOWN COROENTXL INTERBODY; UNKNOWN RELINE POSTERIOR FIXATION; UNKNOWN X-CORE VBR
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 56 KG