AVS Anchor-C Cervical Cage System 48328550Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327126273), received between Apr 12, 2016 and Oct 19, 2018 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2018Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT THE FLEXIBLE DRIVER BENT DURING SCREW INSERTION. THE DEVICE IS STILL INTACT THERE WERE NO BROKEN FRAGMENTS. UPON INSPECTION OF THE RETURNED DEVICE, THE FLEXIBLE SHAFT WAS FOUND TO BE FRACTURED. NO ADVERSE CONSEQUENCES TO THE PATIENT WAS REPORTED. THIS COMPLAINT WILL BE REPORTED AS DEVICE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7987049 ↗
• MalfunctionOct 19, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT A SCREWDRIVER WAS USED PAST ITS LIMITATIONS SPECIFIED IN THE SURGICAL TECHNIQUE AND BROKE. THERE WERE NO BROKEN FRAGMENTS FALLING INTO PATIENT'S CAVITY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A BACKUP SCREWDRIVER. THIS WILL BE REPORTED AS A DEVICE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7987046 ↗
• MalfunctionJun 6, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE DURING SCREW TIGHTENING. ALL FRAGMENTS WERE RETRIEVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW DRIVER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7572737 ↗
• MalfunctionOct 18, 2017Break; Detachment Of Device Component; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; DURING SURGERY WHILE PERFORMING AN ACDF ON C6 C7 THE TIP OF A FLEXIBLE SCREWDRIVER BROKE OFF. ALL BROKEN FRAGMENTS WERE RETRIEVED. SURGERY WAS SUCCESSFULLY COMPLETED USING A STRAIGHT SCREWDRIVER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6960061 ↗
• MalfunctionOct 10, 2017Break; Fracture; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SURGEON WAS IMPLANTING A CAGE AND ON HIS 2ND OF 2 SCREWS, THE SCREWDRIVER BROKE. IT FRACTURED AT ONE OF THE FLEXIBLE JOINTS. THE CASE WAS COMPLETED WITHOUT ISSUE OR PATIENT COMPLICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6935682 ↗
• MalfunctionOct 2, 2017Fracture; Improper or Incorrect Procedure or Method; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; DURING AN ACDF CASE THE SURGEON OVER FLEXED THE FLEXIBLE SCREWDRIVER AND IT SNAPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6908893 ↗
• MalfunctionSep 5, 2017Fracture; Break; Fracture

  IT WAS REPORTED THAT; ATTEMPTED TO INSERT THE CAGE IN C6/7 USING THE FLEXIBLE DRIVER, THE DRIVER WAS BROKEN DUE TO EXCESSIVE ANGLE DURING INSERTION. OTHER STRAIGHT DRIVER WAS USED AND COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6843614 ↗
• MalfunctionJun 13, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; BROKEN SCREWDRIVER DURING IMPLANTATION. NO PATIENT INJURY. SURGERY WAS COMPLETED AS PLANNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6638473 ↗
• MalfunctionApr 11, 2017Fracture; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT; THE SCREWDRIVER FRACTURED WHEN INSERTED THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6482797 ↗
• MalfunctionDec 1, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT USING THE FLEXIBLE SCREWDRIVER IN A CASE, DOCTOR EXCEEDED THE ANGLE LIMITS AND BROKE THE SHAFT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6138232 ↗
• MalfunctionJun 1, 2016Break; Fracture; Material Integrity Problem; Device Handling Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT; DESPITE BEING WARNED (AFTER GOING OVER TECHNIQUE GUIDE) THE DOCTOR OVER ANGLED BOTH DRILL AND DRILL BIT. UPDATE (18-MAY-2016): DEVICE FRACTURE. DELAY, HAD TO USE ANOTHER PRODUCT TO COMPLETE THE PROCEDURE. TOOK OUT ALL OF THE IMPLANTS AND USED ANOTHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5691245 ↗
• MalfunctionApr 12, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; WHILE INSERTING A SCREW WITH THE FLEXIBLE SCREWDRIVER, THE SCREWDRIVER BROKE ABOUT HALF WAY DOWN THE FLEXIBLE PART OF THE SHAFT. THE DRIVER WAS NOT BEING USED AT AN EXCESSIVE ANGLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5569536 ↗