Cabo 81-1216Recalls & reported problems
Seaspine Orthopedics Corporation · Variable -4.0mm Self Tapping, 16mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889981160722), received between Sep 6, 2018 and Jan 21, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Mechanical Problem1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
THE PATIENT UNDERWENT A 2-LEVEL ANTERIOR CERVICAL SPINE SURGERY ON (B)(6) 2020 USING SEASPINE'S CABO ANTERIOR CERVICAL PLATE SYSTEM. IN A 6-WEEK POST OPERATIVE FOLLOW UP APPOINTMENT, IMAGING REVEALED A LOWER SCREW HAD LOOSENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11208403 ↗MalfunctionSep 6, 2018Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
INITIAL ACDF SURGERY AT C7-T1 WAS PERFORMED ON (B)(6) 2017. DURING A ROUTINE FOLLOW UP, IT WAS NOTED THAT THE 16 MM SUPERIOR BONE SCREW HAD FRACTURED AND BACKED OUT FROM THE ANTERIOR CERVICAL PLATE. PATIENT IS FULLY FUSED. SURGEON IS MONITORING THE PATIENT, AND NO REVISION SURGERY IS CURRENTLY PLANNED. PATIENT BONE QUALITY IS UNKNOWN. IT IS UNKNOWN THE PATIENT'S ACTIVITY LEVEL POST-OP. IT IS UNKNOWN IF THE PATIENT COMPLIED W/POSTOPERATIVE CARE INSTRUCTIONS.
Patient problems: Failure of Implant
MAUDE report 7853378 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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