MAUDE Adverse Event Report: SYNERGY SPINE SOLUTIONS INC. SYNERGY DISC; ARTIFICIAL CERVICAL DISC

Catalog Number	1077-3266
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient was a participant in the synergy 1l ide clinical study (b)(6) with an initial implant date of (b)(6) 2022.Implant subsidence was identified.Revision surgery was performed on (b)(6) 2026, during which the synergy disc was explanted and an anterior cervical discectomy and fusion (acdf) procedure was performed.The manufacturer reviewed the applicable batch record, complaint history, and serial radiographs provided by the clinical site.Review of the batch record did not identify manufacturing deviations, nonconformances, or anomalies that could have contributed to the reported event.No additional complaints have been reported for the implanted lot, and no additional complaints involving implant subsidence were identified during review of complaint records.The explanted device has been submitted to an independent laboratory for explant retrieval analysis under the ide study.Retrieval analysis is ongoing.Based on the information currently available, no manufacturing nonconformance has been identified and a definitive root cause cannot be determined.The manufacturer will review the results of the retrieval analysis upon completion and submit supplemental information if warranted.Device usage: this device is used for treatment.If additional information is obtained that is relevant to this report, a follow-up report will be sent.
Event or Problem Description
Patient is participating in the 1l ide trial (b)(6) with initial implant of device in (b)(6) 2022.Asymptomatic implant subsidence was identified at the one-year study visit in (b)(6) 2023.Patient presented in (b)(6) 2026 with worsening of symptoms and underwent physical therapy.In (b)(6) 2026, patient returned to clinic with continued symptoms and elected to undergo surgery.On (b)(6) 2026, the patient underwent revision surgery.The synergy disc was explanted and the patient underwent fusion (acdf) surgery at the same level.

• Brand Name: SYNERGY DISC
• Common Device Name: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SYNERGY SPINE SOLUTIONS INC.; 357 s. mccaslin blvd; suite 120; louisville CO 80027
• Manufacturer (Section G): SYNERGY SPINE SOLUTIONS INC.; 357 s. mccaslin blvd; suite 120; louisville CO 80027
• Manufacturer Contact: emily aulby ; 357 s. mccaslin blvd; suite 120; louisville, CO 80027 ; 7207693270
• MDR Report Key: 25585972
• Report Number: 3014213973-2026-16926
• Device Sequence Number: 14890970
• Product Code: MJO
• UDI-Device Identifier: M670107732660
• UDI-Public: +M670107732660
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P250028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: 09/25/2025
• Device Catalogue Number: 1077-3266
• Device Lot Number: 204126920G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• 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: Other
• Patient Sex: Unknown