AVS Anchor-C 48335310Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04546540679833), received between Mar 1, 2016 and Jan 17, 2024 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2024Migration; Migration

  A PATIENT WAS REVISED TO ADDRESS THE MIGRATION OF AN AVS ANCHOR C SELF-DRILLING SCREW AT C5 APPROXIMATELY TWO MONTHS AFTER IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526336 ↗
• MalfunctionJul 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHEN PLACING TWO AVS ANCHOR-C SELF-DRILLING SCREW THROUGH THE GUIDE INSERTER INTO THE IMPLANT THE LOCKING RINGS POPPED OFF INTRA-OPERATIVELY. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE FIRST SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117308 ↗
• MalfunctionMay 18, 2021Fracture; Positioning Problem; Fracture; Positioning Problem

  IT WAS REPORTED THAT THE ANCHOR C SELF DRILLING BONE SCREW 'DID NOT FIT IN PROPER POSITION' INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11843068 ↗
• MalfunctionMay 12, 2021Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE C-RING OF AN ANCHOR C SCREW DETACHED DURING INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814345 ↗
• MalfunctionApr 2, 2018Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LOCKING RING ON THE SCREW DISENGAGED UPON INSERTION. THE AFFECTED SCREW WAS REPLACED WITH A NEW ONE, WITH A 5 MINUTE SURGICAL DELAY. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7390578 ↗
• MalfunctionJun 27, 2017Detachment Of Device Component; Mechanical Problem; Detachment Of Device Component; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; EXPERIENCED SURGEON/CUSTOMER HAD 3 OCCURRENCES OF LOCKING RING ON SELF DRILLING SCREW DISLODGING DURING NORMAL INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6671771 ↗
• MalfunctionJun 27, 2017Detachment Of Device Component; Mechanical Problem; Detachment Of Device Component; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; EXPERIENCED SURGEON/CUSTOMER HAD 3 OCCURRENCES OF LOCKING RING ON SELF DRILLING SCREW DISLODGING DURING NORMAL INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6671769 ↗
• MalfunctionJun 27, 2017Detachment Of Device Component; Mechanical Problem; Detachment Of Device Component; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; EXPERIENCED SURGEON/CUSTOMER HAD 3 OCCURRENCES OF LOCKING RING ON SELF DRILLING SCREW DISLODGING DURING NORMAL INSERTION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6671763 ↗
• MalfunctionApr 4, 2017Detachment Of Device Component; Mechanical Problem; Device Contamination with Chemical or Other Material; Detachment Of Device Component; Mechanical Problem

  IT WAS REPORTED THAT; DURING AN ACDF CASE, WE WERE IMPLANTING A SELF DRILLING SCREW INTO A 6 MM HEIGHT STAND ALONE CAGE. AS THE SURGEON INSERTED THE SCREW INTO THE BONE, A SMALL BLACK RING POPPED OFF THE TOP OF THE SCREW. AS I HAD NEVER SEEN THIS BEFORE, I WAS UNSURE WHAT IT WAS BUT ADVISED THE SURGEON TO REMOVE THE SCREW AND REPLACE IT WITH A RESCUE SELF DRILLING BONE SCREW. THE HOSPITAL ADMINISTRATOR REMOVED THE SCREW AND THE BLACK RING PIECE THAT POPPED OFF FROM THE STERILE FIELD AND PLACED IT IN A SPECIMEN CUP.

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

  MAUDE report 6458252 ↗
• MalfunctionAug 22, 2016Break; Material Deformation; Material Deformation

  IT WAS REPORTED THAT; SURGEON NOTICED DAMAGED LOCKING CLIP ON SCREW, REPLACED WITH NEW IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5894807 ↗
• MalfunctionJul 15, 2016Detachment Of Device Component; Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT; RING ON SCREW CAME OFF DURING INSERTION. DRILL GUIDES WERE NOT USED-SCREWS WERE FREE-HANDED

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

  MAUDE report 5799809 ↗
• MalfunctionJul 15, 2016Detachment Of Device Component; Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT; RING ON SCREW CAME OFF DURING INSERTION. DRILL GUIDES WERE NOT USED-SCREWS WERE FREE-HANDED

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

  MAUDE report 5799805 ↗
• MalfunctionApr 5, 2016Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT; THE SURGEON WAS PUTTING THE SCREWS INTO THE CAGE AND BEFORE BEING FULLY SEATED THE LOCKING RING WAS COMING OFF. HE WAS NOT USING AN ALL IN ONE GUIDE. WE WERE AT C5-6 AND C6-7.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5547246 ↗
• MalfunctionMar 11, 2016Failure to Advance; Material Distortion

  IT WAS REPORTED THAT THE SCREW WOULD NOT ADVANCE BELOW THE LOCKING MECHANISM OF THE IMPLANT. THE LOCKING RING ON TOP OF THE SCREW APPEARED TO BE DISTORTED. ANOTHER SIZE SCREW WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5496138 ↗
• MalfunctionMar 1, 2016Break; Failure to Advance

  IT WAS REPORTED THAT WHILE PLACING TWO SCREWS INTO A CAGE, THE SCREWS STOPPED ADVANCING AND THE LOCKING RINGS BROKE. THE APPROPRIATE GUIDE WAS USED AND THE HOLES FOR THE SCREWS WERE PREPARED WITH AN AWL AND DRILL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5471065 ↗