Cabo™ 81-1214Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841508101666), received between Oct 27, 2016 and Jan 26, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 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 7222745 ↗
• MalfunctionDec 20, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  INITIAL ACDF SURGERY AT C4-C6 WAS PERFORMED ON (B)(6) 2016. ROUTINE FOLLOW UP AT 2 WEEKS NOTED NO CHANGE TO THE DEVICE. APPROXIMATELY 6 WEEKS POST OPERATIVELY, IT WAS NOTED THAT THE 18MM CAUDAL BONE SCREW HAD BACKED OUT 2-3MM FROM THE ANTERIOR CERVICAL PLATE. PATIENT IS ASYMPTOMATIC. SURGEON IS MONITORING THE PATIENT, AND NO REVISION SURGERY IS CURRENTLY PLANNED. PATIENT BONE QUALITY IS UNKNOWN. THE PATIENT REPORTEDLY DID NOT FALL PRIOR TO THE EVENT. IT IS UNKNOWN IF THE PATIENT COMPLIED W/POST-OPERATIVE CARE INSTRUCTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6190072 ↗
• MalfunctionOct 27, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  INITIAL ACDF SURGERY AT C4-C6 WAS PERFORMED ON (B)(6) 2016. ROUTINE FOLLOW UP AT 2 WEEKS NOTED NO CHANGE TO THE DEVICE. APPROXIMATELY 6 WEEKS POST OPERATIVELY IT WAS NOTED THAT THE 18 MM CAUDAL BONE SCREW HAD BACKED OUT 2-3MM FROM THE ANTERIOR CERVICAL PLATE. PATIENT IS ASYMPTOMATIC. SURGEON IS MONITORING THE PATIENT, AND NO REVISION SURGERY IS CURRENTLY PLANNED. PATIENT BONE QUALITY IS UNKNOWN. THE PATIENT REPORTEDLY DID NOT FALL PRIOR TO THE EVENT. IT IS UNKNOWN IF THE PATIENT COMPLIED W/POST-OPERATIVE CARE INSTRUCTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6062584 ↗