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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Ossification (1428); Pain (1994); Burning Sensation (2146); Osteolysis (2377); Neck Pain (2433); Osteopenia/ Osteoporosis (2651)

Event Date 03/01/2022

Event Type  Injury  

Event Description

A patient underwent a total disc replacement procedure on (b)(6) 2021 at c5-c6 and c6-c7.On (b)(6) 2022 nuvasive rep was notified of possible osteolysis and revision planned for (b)(6) 2022.

Manufacturer Narrative

No product has been returned as the device is still in-situ, radiographs provided are inconclusive and no confirmation could be made.Radiographic review noted plain radiographic evidence of implant subsidence at both levels (both into the c6 vertebra).Ct evidence of periprosthetic radiolucency at the c5, c6, c7 vertebral endplates and vertebral bodies.The ceramic cores at both levels are centered within the endplates.There does not appear to be osteolysis at either level.No definitive root cause of the reported complications could be determined though review of patient and surgeon provided information identified several patient conditions or predispositions that may have cause or contributed to the adverse event as osteogenesis imperfecta type 4, osteoporosis with dexa t score of -2.3, thyroid disorder with low t3 and poor bone quality and considered possible contraindications for use.No additional investigation can be completed, should a revision/removal take place providing more information a follow up report will be completed.Labeling review: "contraindications: simplify® cervical artificial disc should not be implanted in patients with the following conditions: osteoporosis or osteopenia defined as dexa bone mineral density t-score less than -1.5., known allergy to the implant materials (peek, ceramic, titanium), severe facet disease or facet degeneration, bridging osteophytes, marked cervical instability on neutral lateral or flexion/extension radiographs (e.G., radiographic signs of subluxation > 3.0mm or angulation of the disc space more than 11° greater than adjacent segments)"."intraoperative: 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." "anterior cervical surgery risks anterior cervical surgical risks are, but may not be limited to: paresis, soft tissue damage, arm weakness or numbness, dysesthesia or numbness, paresthesia, unresolved pain, surgical intervention at incorrect level, need for supplemental fixation, death." "cervical artificial disc risks risks specific to cervical artificial discs, including the simplify® cervical artificial disc, are but may not be limited to: allergic reaction to the implant materials, device subsidence, excessive device height loss, wear debris, disc space collapse, soft tissue damage, nerve injury, paralysis or weakness that is temporary or permanent, dysesthesia or numbness, paresthesia, failure to relieve symptoms including unresolved pain, additional surgery due to loss of fixation, infection or injury, spontaneous fusion due to heterotopic ossification, development of bridging bone or osteophytes, removal, revision, reoperation or supplemental fixation of the disc, osteolysis, bone loss, or bone resorption, death," "note: additional surgery may be necessary to correct some of the adverse effects." "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.There is a risk of heterotopic ossification associated with artificial cervical discs which could lead to reduced cervical motion or fusion at either the treated level(s) or adjacent levels." "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." still in-situ.

• Brand Name: SIMPLIFY® CERVICAL ARTIFICIAL DISC
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC.; 7475 lusk blvd; san diego VA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 15480545
• MDR Text Key: 300582345
• Report Number: 2031966-2022-00189
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• 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: 08/30/2022
• 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 Age: 52 YR
• Patient Sex: Female