MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SIMPLIFY CERVICAL ARTIFICIAL DISC; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	2-4EV-CE
Medical Device Problem Codes	Break (1069); Crack (1135); Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Osteolysis (2377); Radiolucent Lines (4848)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was confirmed by review of radiograph images showing evidence of periprosthetic radiolucencies, fracture and subsidence of the superior plate of the implant, and possible subsidence of the inferior plate of the implant.No device was available for evaluation, as the device remains in-situ; further, operative notes were not provided for review of usage/technique.Information regarding the patient's post-operative activity levels and bone quality was not provided.Further, the patient did not report having experienced any falls or other trauma.A review of the device history record was performed and no discrepancies relevant to the reported event were found.A definitive root cause was unable to be determined with the information provided.Labeling review: "warnings: correct selection of the appropriate implant size and correct placement of simplify cervical artificial disc are essential to ensure proper performance and functioning of the device.Information regarding implant size selection and correct implant placement is provided in the simplify cervical artificial disc surgical technique guide." "preoperative: patient selection is extremely important.In selecting patients for a total disc replacement, the following factors can be of extreme importance to the success of the procedure: the patient¿s occupation or activity level; a condition of senility, mental illness, alcoholism or drug abuse; certain degenerative diseases that may be so advanced at the time of implantation that the expected useful life of the device is substantially decreased, and medical conditions that may affect postoperative management, such as alzheimer¿s disease and emphysema.The patient should be informed of the potential adverse effects (risks/complications) contained in this insert(see safety results / aes)." "information on the proper implant site preparation, implant size selection, and the use of surgical instrumentation for the simplify cervical artificial disc is provided in the surgical technique guide and should be reviewed prior to surgery.Preoperative planning may be used to estimate the required implant size and to assure that the appropriate range of sizes is available for surgery.Correct selection of the appropriate implant sizes is extremely important to assure the placement and function of the disc.The procedure should not take place if the appropriate range of sizes are not available." "postoperative: patients should be instructed in postoperative care procedures and should be advised of the importance of adhering to these procedures for successful treatment with the device.Heavy lifting (greater than 20lbs) should be avoided for 6 weeks, and impact sports should be avoided for 3 months." "cervical artificial disc risks: risks specific to cervical artificial discs, including the simplify cervical artificial disc, are but may not be limited to: implant failure.Device fatigue or fracture or breakage." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that, approximately 42 months after receiving a cervical total disc replacement at c5/6, the patient was seen for a follow-up and reported having radiating upper extremity pain.Imaging was performed and reviewed by the surgeon, who noted the implant exhibited unspecified damage and seemed to exhibit subsidence at the inferior c5 endplate with a loss of intervertebral height at c5/6.A revision procedure is planned but has not yet occurred.There was no report from the patient of any traumatic events occurring and it is not believed the patient exhibits bone quality issues.No additional information is available at this time.
Event or Problem Description
It was reported that the patient received a simplify prosthesis at c5/6 in (b)(6) 2020.Subsequently, the patient was seen for a follow-up visit and reported having radiating upper extremity pain.Imaging review by the surgeon noted the prosthesis was "destroyed" and seemed to exhibit subsidence at the inferior c5 endplate with a loss of intervertebral height at c5/6.On (b)(6) 2024 a revision took place where the cervical total disc replacement was removed.Surgeon comments provided noted the patient was identified to have an infection (unidentified type) with enlarged soft tissue.The superior end plate was confirmed cracked prior to removal with no fusion to the vertebral body with noted poor bone quality.The inferior plate was noted to have been undamaged and fully fused prior to removal.
Additional Manufacturer Narrative
The reported event was confirmed by review of radiograph images showing evidence of periprosthetic radiolucency, crack and subsidence of the superior plate of the implant.No device was available for evaluation as it was lost by the user facility.Operative notes provided for review stated the patient was identified to have an infection (unidentified type) with enlarged soft tissue.The superior end plate was confirmed cracked prior to removal with no fusion to the vertebral body with noted poor bone quality.The inferior plate was noted to have been undamaged and fully fused prior to removal.The patient's post-operative activity levels were not provided.Further, the patient did not report having experienced any falls or other trauma.A review of the device history record was performed and no discrepancies relevant to the reported event were found.A definitive root cause was unable to be determined with the information provided however observations' and information reviewed indicate contamination resulting in infection, osteolysis/ bone reabsorption, as well as implant selection and placement, excessive space prep and poor bone quality as possible cause or contributors.Post-operative infection is a known complication of surgical procedures that can be the result of environmental contamination, incomplete sterilization or patient related factors.Nuvasive instrumentation is cleaned and sterilized by the user facility and sterilization records were not provided.The sterility of sterile implants involved in the case was confirmed by the vendor and specifications were met records attached.The root cause has not be determined though review of the reported event suggests it may be the result of environmental contamination.No additional investigation can be completed.Labeling review: "contraindications simplify® cervical artificial disc should not be implanted in patients with the following conditions: an active systemic infection or an infection at the operative site.Osteoporosis or osteopenia defined as dexa bone mineral density t-score less than -1.5.Known allergy to the implant materials (peek, ceramic, titanium)¿" "warnings simplify® cervical artificial disc should only be used by surgeons who are experienced with anterior cervical spinal procedures and have undergone hands-on training in the use of this device.Only surgeons who are familiar with simplify® cervical artificial disc components, instruments, procedure, clinical applications, biomechanics, adverse events (aes), and risks associated with simplify® cervical artificial disc should use this device.A lack of adequate experience and/or training may lead to a higher incidence of aes, including neurological complications.Correct selection of the appropriate implant size and correct placement of simplify® cervical artificial disc are essential to ensure proper performance and functioning of the device.Information regarding implant size selection and correct implant placement is provided in the simplify® cervical artificial disc surgical technique guide." "preoperative: in order to minimize the risk of atraumatic periprosthetic vertebral fractures, surgeons must consider all co-morbidities, past and present medications, previous treatments, etc.Upon reviewing all relevant information, the surgeon must determine whether a bone density (dexa) scan is prudent.If dexa is performed, the patient should not receive the device if the dexa bone mineral density t-score is <-1.5, as the patient may be osteoporotic or osteopenic.Patient selection is extremely important.In selecting patients for a total disc replacement, the following factors can be of extreme importance to the success of the procedure: the patient¿s occupation or activity level; a condition of senility, mental illness, alcoholism or drug abuse; certain degenerative diseases that may be so advanced at the time of implantation that the expected useful life of the device is substantially decreased, and medical conditions that may affect postoperative management, such as alzheimer¿s disease and emphysema.The patient should be informed of the potential adverse effects (risks/complications) contained in this insert (see safety results / aes).Information on the proper implant site preparation, implant size selection, and the use of surgical instrumentation for the simplify® cervical artificial disc is provided in the surgical technique guide and should be reviewed prior to surgery.Preoperative planning may be used to estimate the required implant size and to assure that the appropriate range of sizes is available for surgery.Correct selection of the appropriate implant sizes is extremely important to assure the placement and function of the disc.The procedure should not take place if the appropriate range of sizes are not available.The simplify® cervical artificial disc is intended to be used with the simplify® cervical artificial disc instrument set.The simplify® cervical artificial disc instruments are reusable, supplied non-sterile and must be sterilized in accordance with the recommended cleaning and sterilization procedures prior to use.The simplify® cervical artificial disc is supplied sterile.It is not intended to be re-sterilized.Do not use if sterility is compromised." "intraoperative: use aseptic technique when removing simplify cervical artificial disc from the innermost packaging.Carefully inspect each device and its packaging for any signs of damage, including damage to the sterile barrier.Do not use the simplify® cervical artificial disc if the packaging is damaged or if the implant shows signs of damage.Ensure simplify® cervical artificial disc does not come into contact with hard objects that may damage the implant and render the implant functionally unreliable.Visual inspection of the prosthesis is recommended prior to implanting the device.If any part of the device appears damaged or not fully assembled, do not use it.Excessive removal of endplate cortical bone may result in sub-optimal outcomes." "postoperative: patients should be instructed in postoperative care procedures and should be advised of the importance of adhering to these procedures for successful treatment with the device.Heavy lifting (greater than 20lbs) should be avoided for 6 weeks, and impact sports should be avoided for 3 months." "potential adverse effects of device on health below is a list of the potential adverse effects (e.G., complications) identified from the simplify® cervical artificial disc clinical study results, approved device labeling for other cervical total disc replacement devices, and published scientific literature including: (1) those associated with any general surgical procedure; (2) those associated with anterior cervical spine surgery; and (3) those associated with a cervical artificial disc device, including the simplify® cervical artificial disc.In addition to the risks listed below, there is also the risk that surgery may not be effective in relieving symptoms or may cause worsening of symptoms.Additional surgery may be required to correct some of the adverse effects." "general surgery risks general surgical risks are, but may not be limited to: infection/abscess/cyst, localized or systemic." "anterior cervical surgery risks anterior cervical surgical risks are, but may not be limited to: infection/abscess/cyst, localized or systemic.Vertebral body fracture.Dysesthesia or numbness" "cervical artificial disc risks specific to cervical artificial discs, including the simplify® cervical artificial disc, are but may not be limited to: infection/abscess/cyst, localized or systemic, allergic reaction to the implant materials, implant failure, device migration, device subsidence, device fatigue or fracture or breakage, device instability, separation of device components, placement difficulties, device malposition, improper device sizing, disc space collapse, material degradation kyphosis or hyper-extension, soft tissue damage, additional surgery due to loss of fixation, infection or injury, removal, revision, reoperation or supplemental fixation of the disc, osteolysis, bone loss, or bone resorption." if the device is obtained for examination, a supplemental report will be filed accordingly.

• Brand Name: NUVASIVE SIMPLIFY CERVICAL ARTIFICIAL DISC
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• 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: 18832886
• Report Number: 2031966-2024-00071
• Device Sequence Number: 7458118
• Product Code: MJO
• UDI-Device Identifier: 00843285101969
• UDI-Public: 843285101969
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 2-4EV-CE
• Device Catalogue Number: N/A
• Device Lot Number: 3690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female