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

Model Number	2-5L-CE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Stenosis (2263)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2022 a revision surgery occurred due to severe foraminal stenosis secondary to heterotopic ossification as a result of an ongoing metabolic condition.Where there was a vertebral corpectomy at c4/5, anterior cervical discectomy and fusion at c5/6 and one simplify disc was explanted.No additional issues were reported.
Additional Manufacturer Narrative
The device was returned directly to a third party lab for evaluation and a follow up report will be filed after completion of the investigation.Review of the reported series of events identified the patient previously received posterior fixation while leaving the motion preservation devices in place and may be a contributing factor to the ossification.A definitive cause of the reported ossification cannot be determined though post-operative ossification is a known complication of total disc replacement and represented in the product labeling.Labeling review: "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." "risks specific to cervical artificial discs, including the simplify cervical artificial disc, are but may not be limited to: failure to relieve symptoms including unresolved pain, removal, revision, reoperation or supplemental fixation of the disc." "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." "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.
Event or Problem Description
New and updated information listed on section h10.
Additional Manufacturer Narrative
The disc replacement at c6/7 was left in-situ but the disc replacement at c5/6 was sent directly to a third party lab for evaluation, no radiographs were provided so the complaint was not confirmed.Review of the reported event noted no product malfunction but rather severe foraminal stenosis secondary to the heterotopic ossification as result of an ongoing metabolic condition.Additionally note the patient has a history of spinal procedures related to this pathology one of which (200067424) consisted of posterior fixation from c3/7 (due to a lack of relief of pre-surgical pain) eliminating motion at these vertebral levels increasing susceptibility to the noted heterotopic ossifications identified in conjunction with the noted adjacent c4/5 required corpectomy indicate the root cause of the event as continued pathology as a result of patient related factors.No additional investigation required.Examination and review of the surgeon provided information and explanted disc and from c5/6 was completed by a third party lab and surgeon and found limited damage to the implant components that occurred at time of the explantation.The damage incurred was identified to be the result of the disc removal procedure where it was notably completed utilizing a penfield 4 and osteotome and drilling technique to free the endplate from bone.The wear characteristics of the implant over the four years showed burnishing consistent with mode 1 wear.The review noted "the device features are not solely causally related to the need for revision surgery." manufacturing review: review of the device history record notes no material non-conformance¿s, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: "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." "precautions the safety and effectiveness of the simplify® cervical artificial disc has not been established in patients with the following conditions.History of an endocrine or metabolic disorder (e.G., paget¿s disease) known to affect bone and mineral metabolism." "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." "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, arm weakness or numbness." "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 instability, loss of flexibility, 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, spontaneous fusion due to heterotopic ossification, development of bridging bone or osteophytes, periarticular calcification and fusion, development of spinal conditions, including but not limited to spinal stenosis, removal, revision, reoperation or supplemental fixation of the disc." "note: additional surgery may be necessary to correct some of the adverse effects.During the procedure, if the simplify® cervical artificial disc cannot be visualized, a contrast media may be used." "following completion of the procedure, patients should receive a postoperative treatment care protocol.Patients will be permitted to ambulate on the day of surgery, as tolerated, and, at the discretion of the surgeon, may wear a collar to support the neck (philadelphia, aspen, miami j, 2 poster-orthosis, etc.) until the soft tissues of the neck have healed." h3 other text : sent directly to third party lab.

• Brand Name: SIMPLIFY CERVICAL ARTIFICIAL DISC
• Common Device Name: 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 CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16230146
• Report Number: 2031966-2023-00008
• Device Sequence Number: 14770475
• Product Code: MJO
• UDI-Device Identifier: 00843285101990
• UDI-Public: 843285101990
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: 2-5L-CE
• Device Lot Number: 2909
• Was Device Available for Evaluation?: Yes
• 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: 12/29/2022
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2-5L-CE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 157 KG