Meridian RA1-211210Recalls & reported problems
Seaspine Orthopedics Corporation · No-Profile Interbody, 35mm x 27mm x 12mm, 10 Deg · Class 2 · Implant
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 10889981215361), received between Apr 15, 2021 and Apr 15, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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
- Difficult or Delayed Positioning1
- Difficult to Remove1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 15, 2021Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove
ON (B)(6) 2021, THE PATIENT UNDERWENT SINGLE-LEVEL (L5-S1) ALIF SPINAL SURGERY CONSISTING OF SEASPINE'S MERIDIAN SYSTEM. DURING THE SURGERY, THE SURGEON ATTEMPTED TO PLACE A STAND-ALONE, NO- PROFILE INTERBODY, WHICH FEATURED TWO DOWNWARD ANCHORS AND ONE UPWARD SCREW. THE SURGEON DETERMINED THE PLACEMENT WAS NOT IDEAL, AND ATTEMPTED TO REMOVE THE ANCHOR TO ALLOW FOR REPOSITIONING, CREATING A BONE VOID DURING THE REMOVAL PROCESS. THE BONE VOID WAS TOO LARGE TO ACCOMMODATE ANY TYPE OF FIXATION IN THAT LOCATION, SO THE SURGEON COMPLETED THE CASE BY PLACING ONE DOWNWARD SCREW. THE FINAL CONSTRUCT CONSISTED OF A THREE-HOLE STAND-ALONE, NO-PROFILE INTERBODY FIXATED BY ONE UPWARD SCREW AND ONE DOWNWARD SCREW, WITH A VOID AT THE THIRD HOLE.
Patient problems: Unspecified Tissue Injury
MAUDE report 11675881 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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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