Cabo™ 81-0234Recalls & reported problems
Neurostructures, Inc · 2 LEVEL PLATE 34mm · Class 2 · Implant
Data updated Oct 13, 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 00841508101376), received between Jan 26, 2018 and Jan 26, 2018 — classified as 1 malfunction.
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
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2018Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
SURGEON HAD TO REVISE AN ACDF PATIENT THAT WAS JUST OVER 3 MONTHS OUT. PHYSICIAN NOTED AT 3 WEEKS THAT ONE OF THE SCREWS ON THE BOTTOM OF THE PLATE HAD BACKED OUT "ONE TURN". HE DID NOT SURGICALLY INTERVENE AT THAT TIME. THE PATIENT LATER REPORTED HEARING A POP (APPROXIMATELY 13 WEEKS POST-OP). THE PATIENT WAS SEEN BY THE SURGEON AFTER THIS EVENT. THE X-RAY REVEALED THE BOTTOM SCREW HAD BACKED OUT FURTHER, AND BOTH OF THE TOP SCREWS WERE BROKEN CLOSE TO MID-SHAFT. THE SURGEON TOOK THE PATIENT BACK TO SURGERY AND REMOVED THE PLATE AND SCREWS, EXCEPT FOR THE 2 BROKEN TIPS WHICH HE LEFT IN THE BONE. THE SURGEON CHOSE NOT TO RE-PLATE. THE PATIENT WAS PUT IN A HARD COLLAR AND WILL BE MONITORED TO SEE IF FURTHER INTERVENTION IS NEEDED.
Patient problems: Failure of Implant
MAUDE report 7222713 ↗
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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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