AVS Anchor-C Cervical Cage System 48328500Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327267082), received between Mar 10, 2016 and Dec 28, 2018 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2018Fracture; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF SCREWDRIVER BROKE OFF INTRA-OP. ALL BROKEN FRAGMENTS WERE RETRIEVED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

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

  MAUDE report 8203663 ↗
• MalfunctionDec 26, 2018Fracture; Break; Fracture; Difficult to Remove

  IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER SHEARED OF IN THE SCREW. BROKEN FRAGMENTS COULDN'T BE REMOVED. THE SURGEON TRIED TO DRILL THE PIECE OUT WITH NO LUCK. NEXT, THE SURGEON CREATED A HOLE TO INSERT THE REMOVAL TOOL HOWEVER STILL UNABLE TO REMOVE SCREW. THE SURGEON REMOVED THE CAGE AND SCREWS BY DRILLING AROUND THE IMPLANT TO FREE UP THE SCREWS ENOUGH TO PULL CAGE OUT. A SURGICAL DELAY TIME HAS NOT BEEN SPECIFIED.

  Patient problems: Device Embedded In Tissue or Plaque; Injury; No Consequences Or Impact To Patient

  MAUDE report 8195959 ↗
• MalfunctionOct 19, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT A SCREWDRIVER TIP BROKE WHILE INSERTING A SCREW. THE TIP WAS RETRIEVED FROM THE HEAD OF THE SCREW AND AN ALTERNATE SCREWDRIVERS WAS USED TO FULLY SEAT THE SCREW. THE EVENT RESULTED IN 5 MINUTE SURGICAL DELAY TO RETRIEVE THE SCREWDRIVER TIP. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

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

  MAUDE report 7987042 ↗
• MalfunctionJul 11, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE DURING SCREW INSERTION. ALL BROKEN FRAGMENTS WERE RETRIEVED AND THE PROCEDURE AS SUCCESSFULLY COMPLETED WITH AN ALTERNATE INSTRUMENT. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679312 ↗
• MalfunctionJun 27, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE DOCTOR WAS PLACING THE SCREWDRIVER INTO THE GUIDE, HE HEARD A SNAP AND SUCCESSFULLY REMOVED THE BROKEN PIECES. HE THEN ATTEMPTED TO COMPLETE THE PROCEDURE WITH ANOTHER SCREWDRIVER WHICH ALSO BROKE. AN ALTERNATE SCREWDRIVER WAS ULTIMATELY USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7644501 ↗
• MalfunctionJun 19, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE DOCTOR PLACED THE SCREWDRIVER INTO GUIDE, A SNAP WAS HEARD. HE REMOVED THE BROKEN PIECES AND TRIED AGAIN WITH A SECOND DRIVER, THAT ALSO SNAPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SCREWDRIVER IN THE SET. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7615994 ↗
• MalfunctionMay 9, 2017Break; Fracture; Sticking; Fracture

  IT WAS REPORTED THAT; SCREWDRIVER TIP BROKE AND STUCK IN SCREW HEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553971 ↗
• MalfunctionMar 20, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE SCREWDRIVER WAS BEING IMPACTED BECAUSE OF HARD BONE, VERY TIP OF SCREWDRIVER BROKE. HE HAD ONLY USED THE AWL NOT A DRILL. HE USED A SELF TAPPING SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6419436 ↗
• MalfunctionFeb 13, 2017Fracture; Fracture

  IT WAS REPORTED THAT DURING A CERVICAL FUSION PROCEDURE, A PIECE OF THE SCREWDRIVER BROKE OFF. IT WAS NOTICED WHEN PUTTING THE INSTRUMENT BACK IN THE SET, THAT A LITTLE PIECE (1MM BY 1MM) WAS MISSING. THE MISSING PIECE WAS NOT FOUND ON THE OPERATING TABLE OR IN THE SET. THEREFORE RX EXAMINATIONS WERE DONE TO FIND OUT IF THE PIECE WAS STILL PRESENT IN THE PATIENT (SEE ATTACHED IN INTAKE TAB).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6327501 ↗
• MalfunctionAug 15, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5877310 ↗
• MalfunctionAug 11, 2016Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT THE SURGEON WAS IMPLANTING THE SCREW AND THE TIP OF THE SCREWDRIVER SHEARED OFF IN THE SCREW HEAD. SURGEON WAS UNABLE TO RETRIEVE THE SHEARED PORTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5869087 ↗
• MalfunctionMar 22, 2016Fracture; Material Integrity Problem; Break; Detachment Of Device Component; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT: THE SCREWDRIVER HEAD BROKE OFF IN SCREW HEAD. WE COULD NOT REMOVE THE PIECE OF METAL NOR THE SCREW SO SCREWDRIVER HEAD REMAINED IN SCREW IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5517418 ↗
• MalfunctionMar 10, 2016Material Deformation; Material Integrity Problem; Device Operates Differently Than Expected; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT; THE DRIVER WILL NO LONGER HOLD A SCREW ON THE END. DROPPED A SCREW INTO THE WOUND OFF THE TIP OF THE INSERTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5492321 ↗