Cabo 81-0354Recalls & reported problems
Seaspine Orthopedics Corporation · 3 Level Plate, 54mm · Class 2 · Implant
Data updated Oct 16, 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 10889981160487), received between Jan 7, 2020 and Jan 7, 2020 — classified as 1 injury.
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.
Most reported problems
Device problems
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2020Fracture; Fracture
ON (B)(6) 2019, A CABO ANTERIOR CERVICAL PLATE REVISION TOOK PLACE. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2019 WHERE THE PATIENT UNDERWENT SPINE SURGERY USING THE CABO ANTERIOR CERVICAL PLATE SYSTEM, CONTAINING A 3-LEVEL PLATE AND 8 SCREWS. THE CONSTRUCT ALSO CONSISTED OF 3 SHORELINE ACS INTERBODIES. A REVISION SURGERY TOOK PLACE ON (B)(6) 2019. IT WAS REPORTED THAT THE REVISION SURGERY WAS TO FUSE C7/T1 AND ALSO TO REVISE 2 SCREWS THAT LOOSENED AND 1 ADDITIONAL SCREW THAT HAD BACKED OUT DUE TO A CRACK IN THE CABO CERVICAL PLATE. IT WAS REPORTED THAT THE MOST INFERIOR LOCKING MECHANISM ON THE PLATE HAD BROKEN ALLOWING THE SCREW TO BACK OUT. THE REVISION SURGERY WAS TO REVISE AND REMOVE THE SCREWS AT THE LOWEST LEVEL AND ADD SHORELINE AT THE ADJACENT LEVEL TO THE PLATE. THE CRACKED CABO PLATE WAS LEFT IN THE PATIENT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS REPORTEDLY DOING WELL.
Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9560825 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
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- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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