Aranax Anterior Cervical Plating System T086-1200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M697T08612001), received between Jan 8, 2021 and Feb 11, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 1/17/2022 IN WHICH IT WAS REPORTED THAT SYSTEM SCREWDRIVERS WERE ASSESSED AS DAMAGED AND REQUESTED TO BE REPLACED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. ALTERNATE AVAILABLE INSTRUMENTS WERE USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. THE COMPLAINT INSTRUMENTS WERE RECEIVED AT THE MANUFACTURER ON 1/28/2022 FOR COMPLAINT ASSESSMENT. THIS REPORT IS ASSOCIATED WITH 3005031160-2022-00013.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518753 ↗
• MalfunctionFeb 11, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 1/17/2022 IN WHICH IT WAS REPORTED THAT SYSTEM SCREWDRIVERS WERE ASSESSED AS DAMAGED AND REQUESTED TO BE REPLACED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. ALTERNATE AVAILABLE INSTRUMENTS WERE USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. THE COMPLAINT INSTRUMENTS WERE RECEIVED AT THE MANUFACTURER ON 1/28/2022 FOR COMPLAINT ASSESSMENT. THIS REPORT IS ASSOCIATED WITH 3005031160-2022-00014.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518752 ↗
• MalfunctionJun 9, 2021Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON 5/14/2021 OF A SYSTEM SCREWDRIVER WITH A DISTAL TIP THAT MALFUNCTIONED DURING AN ACDF PROCEDURE ON (B)(6) 2021. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN AVAILABLE ALTERNATE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH ARRIVED AT THE COMPANY FOR COMPLAINT ASSESSMENT ON 5/19/2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11966979 ↗
• MalfunctionJan 8, 2021Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 FROM A SALES REPRESENTATIVE THAT STATED THE TIP OF A SYSTEM SCREWDRIVER FRACTURED DURING AN ACDF PROCEDURE. THE FRACTURED PORTION OF THE SCREWDRIVER WAS RECOVERED, AND AN ALTERNATE SCREWDRIVER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE INSTRUMENT, WHICH ARRIVED AT THE COMPANY FOR ASSESSMENT ON 1/05/2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11143140 ↗