Synergy Disc 1077-3266Recalls & reported problems
Synergy Spine Solutions Inc · SYNERGY DISC, MEDIUM, 6MM, 6° · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M670107732660), received between Jun 22, 2026 and Jun 22, 2026 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
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.
Patient problems: Bacterial Infection; Pain
MAUDE report 25585972 ↗
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- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall4 reports
- Prodisc C SK PDSXL5Centinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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