MAUDE Adverse Event Report: NUVASIVE INC SIMPLIFY DISC; MANUAL INSTRUMENTS DESIGNED FOR USE WITH TOTAL DISC REPLACEMENT DEVICES

Model Number SM-4

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Neck Pain (2433); Vertebral Fracture (4520)

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

The product was returned to a third-party lab for evaluation.Post evet radiographs provided confirm the disc is not ideally positioned and ta vertebral fracture was observed.The patient post-op physical activity is unknown and it is unknown if they experience a fall previously.Review of the reported event deidentified the event initiated following an abrupt patient sneeze suggesting excessive force as possible root cause.No pre-event radiographs have been provided to confirm index placement and amount of migration.With the information provided the root cause is considered unknown however, procedure and risk review identify implant selection, proper placement, delay bone growth and excessive post-op physical activity as possible cause or contributors.No additional investigation can be completed at this time.Should more information be obtained an additional report will be filed.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.Removal of the disc may be required during device re-positioning or for other surgical considerations.This process could cause damage that is not visually apparent¿if a disc is removed during the implantation procedure, a new device should be implanted in its place." "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." "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." "cervical artificial disc risks specific to cervical artificial discs, including the simplify cervical artificial disc, are but may not be limited to: vertebral body fracture, 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, excessive device height, disc space collapse, vertebral body fracture, additional surgery due to loss of fixation, infection or injury, and removal, revision, reoperation or supplemental fixation of the disc.".

Event Description

On (b)(6) 2023 a patient underwent a total disc replacement procedure at c6-c7.On (b)(6) 2023 the patient reportedly sneezed and felt pain, during surgeon examination he identified the disc migrated and the patients inferior end plate fractured on the rt side and disc space collapsed.The patients bone quality was reported as good.On (b)(6) 2023 a revision took place where the disc was removed and replaced with another manufactures device.

• Brand Name: SIMPLIFY DISC
• Type of Device: MANUAL INSTRUMENTS DESIGNED FOR USE WITH TOTAL DISC REPLACEMENT DEVICES
• 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: 17725730
• MDR Text Key: 323169733
• Report Number: 2031966-2023-00192
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843285100009
• UDI-Public: 843285100009
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SM-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2023
• 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
• Patient Age: 54 YR
• Patient Sex: Female