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

Model Number	LG-5
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), 2023 during a simplify disc replacement procedure part of the titanium coating on the endplate of the implant chipped off during implantation where a tamp was utilized.Some coating flaked off mainly from the superior end plate and a little from the inferior.The surgeon removed the chips he saw, but it cannot be confirmed that 100% of the flakes were removed.The device was left in-situ.No patient injury was reported.
Additional Manufacturer Narrative
No product was returned as it is in-situ.Photographs provided confirmed the event.Though no definitive root cause can be determined review of the information provided from the attending rep suggests inadvertent contact with the tamp and or inserter as the cause or contributor of the ti flaking and or insufficient slot formation creating resistance and excessive force/friction during placement or too step of an approach while inserting allowing the tip of the fins on the superior plate to contact superior vertebral end plate and incurring the damage observed all of which could be the consequence of surgical technique.No additional investigation can be completed.Manufacturer 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.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.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.Intraoperative: 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.Cervical artificial disc risks: risks specific to cervical artificial discs, including the simplify cervical artificial disc, are but may not be limited to: wear debris.
Additional Manufacturer Narrative
During investigation of the reported event, it was been determined that no death or serious injury was reported as a result of this malfunction.Additionally, this malfunction has not previously caused or contributed to a death or serious injury on a same/similar device.Therefore, the initial report was submitted in error.

• 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: 16623171
• Report Number: 2031966-2023-00054
• Device Sequence Number: 4572294
• Product Code: MJO
• UDI-Device Identifier: 00843285100108
• UDI-Public: 843285100108
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/30/2023

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: 06/27/2026
• Device Model Number: LG-5
• Device Lot Number: W83572
• 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: 03/02/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TMP TAMP; UNKNOWN ILG INSERTER
• Patient Sex: Prefer Not To Disclose