Meridian RA2-001003Recalls & reported problems
Seaspine Orthopedics Corporation · Interbody Inserter · Class 2
All models of Meridian (8)
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 10889981216108), received between Apr 5, 2021 and Apr 5, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).
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.
Most reported problems
Device problems
- Physical Resistance/Sticking1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2021, THE PATIENT UNDERWENT L3-L5 ALIF SPINAL SURGERY USING THE SEASPINE MERIDIAN SYSTEM. DURING SURGERY, THE INTERBODY INSERTER WOULD NOT DISENGAGE FROM THE INTERBODY, NECESSITATING REMOVAL OF THE INTERBODY. BECAUSE OF THIS A VESSEL WAS NICKED, CAUSING SIGNIFICANT BLEEDING. THE VASCULAR SURGEON HAD TO INTERVENE TO PREVENT FURTHER BLEEDING. THE CASE WAS COMPLETED WITH NO ADDITIONAL INTERVENTION NEEDED. THE PATIENT HAS NOT EXPERIENCED ANY POST OPERATIVE COMPLICATIONS.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 11614886 ↗
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- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 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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