Atoll 16-33-0170Recalls & reported problems
Seaspine Orthopedics Corporation · Pre-Bent Occipital Rod (110 degrees -170mm). The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981034498), received between Apr 11, 2026 and Apr 11, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Limb Pain1
- Neck Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2026Fracture
ORTHOFIX WAS MADE AWARE ON 17 MAR 2026 THAT A PATIENT UNDERWENT A SPINAL SURGERY CONSISTING OF THE ATOLL AND SIERRA OCT SYSTEMS. THE INDEX SURGERY WAS PERFORMED ON (B)(6) 2021 INVOLVING A POSTERIOR CONSTRUCT SPANNING FROM OCCIPITAL TO T2. THE PATIENT REPORTEDLY REMAINED HOSPITALIZED FOR APPROXIMATELY ONE WEEK POSTOPERATIVELY DUE TO COMPLICATIONS AND PAIN. THERE WERE THEN FOLLOW-UPS CONDUCTED FOR APPROXIMATELY 3 MONTHS, AFTER WHICH CARE WAS DISCONTINUED AT THE SURGEON'S DISCRETION. THE PATIENT REPORTED A PERSISTENT AUDIBLE NOISE POST-IMPLANTATION. THE PATIENT WAS THEN SEEN ON (B)(6) 2022 BY A DIFFERENT SURGEON THAN THE ONE THAT PERFORMED THE INDEX SURGERY. AT THIS FOLLOW-UP, THE PATIENT REPORTED PAIN IN THE RIGHT SIDE OF THE NECK, SHOULDER, AND ARM. THE PATIENT WAS DIAGNOSED WITH CERVICAL PSEUDARTHROSIS AT C1C2, A FRACTURED ROD BREAKAGE AT C1C2 ON THE LEFT, SCREW LOOSENING IN THE OCCIPITAL PLATE, BILATERAL C1, BILATERAL C2, LATERAL POSITIONING OF T2 SCREW ON THE RIGHT, AND LATERAL MASS SCREW LOOSENING AT C3, C4 AND C5. A REVISION SURGERY WAS THEN CONDUCTED ON (B)(6) 2022. POST-OPERATIVELY, THE PATIENT REPORTED ONGOING PAIN AT T2-T3, NERVE-RELATED SYMPTOMS INCLUDING SCAPULAR AND SHOU
Patient problems: Limb Pain; Neck Pain
MAUDE report 24849124 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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