Cabo™ 81-1216Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841508101673), received between Oct 24, 2017 and Jan 26, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2018Fracture; Mechanical Problem; Fracture; Mechanical Problem

  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 7223037 ↗
• MalfunctionJan 26, 2018Fracture; Mechanical Problem; Fracture; Mechanical Problem

  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 7222557 ↗
• MalfunctionNov 2, 2017Fracture; Fracture

  POST-OP LEFT SIDE CAUDAL SCREW FRACTURE. POST-OP RIGHT SIDE SCREW BACK OUT. SURGERY ON (B)(6) 2017. FOUND ON ROUTINE FOLLOW UP BY CLINICIAN. THE SAME CLINICIAN AS PER (B)(4) AND (B)(4). PATIENT ASYMPTOMATIC, PLAN WILL BE TO MONITOR PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 6998232 ↗
• MalfunctionOct 24, 2017Fracture; Fracture

  POST-OP SCREW BREAKAGE IN PATIENT. C4-6 ACDF. SURGERY (B)(6) 2017. FOUND ON ROUTINE FOLLOW UP BY CLINICIAN. THE SAME CLINICIAN AS PER (B)(4). PATIENT ASYMPTOMATIC, PLAN WILL BE TO MONITOR PATIENT.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6973506 ↗
• MalfunctionOct 24, 2017Fracture; Fracture

  POST-OP SCREW BREAKAGE IN PATIENT. C5-7 ACDF. SURGERY (B)(6) 2017. FOUND ON ROUTINE FOLLOW UP. PATIENT ASYMPTOMATIC, PLAN WILL BE TO MONITOR PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 6973117 ↗