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

Model Number	LG-5L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Cyst(s) (1800); Stenosis (2263); Radiolucent Lines (4848)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 a total disc replacement was conducted at c6/7.In (b)(6) 2023 an explant surgery was conducted for unspecified reasons.
Additional Manufacturer Narrative
Product was returned directly to a third party lab where the investigation is underway and no results have been provided at this time.Review of the images provided identified radiolucencies with possible implant subsidence, disc space narrowing at the c3-c4 and c5-c6 levels with osteophytes at the anterior margins.At the c6-c7 level, there is a linear radiolucency above the superior ctdr endplate with a radiolucent cyst posteriorly; there is a large radiolucent zone below the inferior ctdr endplate that extends the entire anterior-posterior length of the implant.The patient's bone quality is unknown.Review of the reported event and images were unable to determine a root cause at this time although bone quality, adjacent segment disease, and patient selection as possible cause or contributors as no definitive root cause can be determined at this time.A follow up report will be submitted upon completed evaluation of explant.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." "preoperative: in order to minimize the risk of atraumatic periprosthetic vertebral fractures, surgeons must consider all comorbidities, 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." "cervical artificial disc risks risks specific to cervical artificial discs, including the simplify cervical artificial disc, are but may not be limited to: device subsidence.Removal, revision, reoperation or supplemental fixation of the disc, osteolysis, bone loss, or bone resorption.".
Event or Problem Description
On (b)(6) 2023 a total disc replacement was conducted at (b)(6).In (b)(6) 2023 an explant surgery was conducted due to periprosthetic radiolucencies observed in radiographs with possible implant subsidence.Patient tested positive for c.Acne.
Additional Manufacturer Narrative
The device was received by a third-party lab for evaluation although the complaint could not be confirmed.The disc was evaluated by a third-party lab and surgeon evaluator dr.(b)(6) who confirmed a limited visible loss of the titanium coating on the peek surface that possibly occurred at time of the explantation rather than during placement although evidence of embedded debris was noted suggest both may have taken place.Impingement marks were also observed on both plate anterior side flat surface.No lab reports were provided but postoperative surgeon notes and the complaint statement identified the patient tested postoperative for a p-acne infection and subsequently developed subsidence, bone loss and cystic changes which is likely the root cause of the revision procedure.A cross sectional micro ct analysis noted wear characteristics for a device implanted for almost eight months were consistent with mode 1 wear, there was no pathology submitted to calculate alval score for possibility of patient hypersensitivity to mode 1 wear debris.And no evidence of catastrophic implant failure.No definitive root cause could be determined although the reported p-acne infection incurred and subsequent endplate subsidence may be the result of an environmental contamination.The nuvasive implants utilized in this case vendor sterilization records show no variation or noted problems with the sterilization process and the devices were considered sterile at time of release.Nuvasive instrumentation utilized in the case are cleaned and sterilized by the end user facility prior to use and no sterilization records were provided.Postoperative infections are a well known complication of spinal surgery and no additional investigation is required.Manufacturing review: review of the device history record notes no material non-conformance, 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: "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 comorbidities, 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.Excessive removal of endplate cortical bone may result in suboptimal 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.Device subsidence.Wear debris.Vertebral body fracture.Dysesthesia or numbness, paresthesia, failure to relieve symptoms including unresolved pain.Removal, revision, reoperation or supplemental fixation of the disc, osteolysis, bone loss, or bone resorption." changes found in sections a2, a3, b3, b4, b5, d6, g3, g4, g6, h2, h3, h6, h10.

• 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: 18030442
• Report Number: 2031966-2023-00243
• Device Sequence Number: 5954252
• Product Code: MJO
• UDI-Device Identifier: 00843285100115
• UDI-Public: 843285100115
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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 Model Number: LG-5L
• Device Lot Number: W85423
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male