AVS Anchor-C 48335312Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540679840), received between Mar 30, 2017 and Jul 27, 2022 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 SECOND SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117273 ↗
• InjuryMar 16, 2021Migration; Migration

  IT WAS REPORTED THAT AN ANCHOR C SELF DRILLING SCREW AT C5 BACKED OUT OF A CAGE POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED WHERE THE SCREW WAS REPLACED AND THE CAGE WAS RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499194 ↗
• MalfunctionJul 14, 2020Migration; Migration

  IT WAS REPORTED THAT AN ACHOR C SELF DRILLING SCREW MIGRATED POST-OPERATIVELY. IT WAS NOTICED VIA X-RAY THAT THE SCREW BEGAN TO BACK OUT APPROXIMATELY 1 MONTH POST-OPERATIVELY. THERE ARE NO PLANS FOR REVISION SURGERY AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10270879 ↗
• InjuryMay 6, 2020Migration; Migration

  PHYSICIAN DISCOVERED VIA X-RAY THAT AN ANCHOR-C SELF DRILLING BONE SCREW BACKED OUT 6-MONTHS POST-OPERATIVELY. FUSION WAS CONFIRMED TO HAVE BEEN ACHIEVED. REVISION SURGERY HAS BEEN PERFORMED AND THE SCREW HAS BEEN REMOVED.

  Patient problems: Injury

  MAUDE report 10028577 ↗
• InjuryApr 30, 2018Unintended Movement; Device Slipped; Unintended Movement

  IT WAS REPORTED THAT ONE MONTH POST OPERATION, A FILM SHOWED THAT A SCREW BACKED OUT. THERE WERE NO ISSUES DURING THE FOUR LEVEL FUSION CASE AND THE SURGEON WAS ABLE TO SEAT THE SCREW PAST THE BLACK RING AROUND THE SCREWDRIVER INTO THE CAGE INSERTER. UPON FOLLOW UP WITH THE SURGEON, THE PATIENT IS DOING WELL.

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

  MAUDE report 7474269 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CALLED IN TO REPORT THAT SINCE CERVICAL SURGERY IN (B)(6) 2015, HE'S HAD PRESSURE IN HIS THROAT AND NO RELIEF, NECK PAIN, HEADACHES THAT CAN AND DO BECOME VERY SEVERE, POPPING AND SHIFTING FEELING IN NECK, RIPPING- GRINDING- FEELING WHEN TURNING HEAD, LOSS OF MENTAL ALERTNESS, PAIN IN THROAT THAT PROJECTS TO MY STOMACH, AND LIST OF OTHERS. AT THIS TIME THE PATIENT HAD NOT HAD ADDITIONAL SURGERY.

  Patient problems: Discomfort; Dizziness; Headache; Nausea; Pain

  MAUDE report 7430803 ↗
• MalfunctionDec 27, 2017Improper or Incorrect Procedure or Method; Device Or Device Fragments Location Unknown; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT; THE SURGEON WAS UNDERTAKING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH THE INTENTION OF IMPLANTING A CAGE AND SCREWS. THE CLINICAL SUPPORT SPECIALIST WAS IN THE CASE. THE SURGEON IMPLANTED THE CAGE AND SCREWS AND THEN DECIDED TO MOVE ONE OF THE SCREWS. AT THIS POINT NO X-RAY WAS BEING USED. THE SURGEON THOUGHT HE HAD TAKEN THE SCREW OUT AND HANDED THE SCREWDRIVER BACK TO THE SCRUB NURSE. THE NURSE STATED THAT HE DID NOT HAVE THE SCREW AND THE SURGEON SUGGESTED THAT HE / THE SCRUB TEAM LOOK FOR THE SCREW. NOT REALISING THAT THE FIRST SCREW WAS STILL IN SITU, THE SURGEON THEN ATTEMPTED TO INSERT A DIFFERENT SCREW AND FOUND IT DIFFICULT TO INSERT. THE SURGEON SAID THAT THE SCREW WAS DIFFICULT TO INSERT AND ASKED IF THERE WAS A TOOL THAT COULD HELP. THE CLINICAL SUPPORT SPECIALIST, ALSO UNAWARE THAT THE SCREW WAS STILL IMPLANTED, SUGGESTED THAT A SHARP SHOOTER, AWL OR DRILL COULD POTENTIALLY HELP.THE SURGEON THEN USED AN AWL AND A HAMMER TO CREATE A PATHWAY FOR THE SECOND SCREW. HOWEVER, THIS ADVANCED THE FIRST SCREW PAST THE POINT ON THE CAGE WHERE IT SHOULD STOP. HE THEN USED A DRILL WHICH ADVANCED THE SCREW FURTHER. HE THEN PUT IN A SECOND SCREW WHICH PUSH

  Patient problems: Device Embedded In Tissue or Plaque; Spinal Cord Injury

  MAUDE report 7147504 ↗
• InjuryDec 27, 2017Difficult to Insert; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT; THE SURGEON WAS UNDERTAKING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH THE INTENTION OF IMPLANTING A CAGE AND SCREWS. THE CLINICAL SUPPORT SPECIALIST WAS IN THE CASE. THE SURGEON IMPLANTED THE CAGE AND SCREWS AND THEN DECIDED TO MOVE ONE OF THE SCREWS. AT THIS POINT NO X-RAY WAS BEING USED. THE SURGEON THOUGHT HE HAD TAKEN THE SCREW OUT AND HANDED THE SCREWDRIVER BACK TO THE SCRUB NURSE. THE NURSE STATED THAT HE DID NOT HAVE THE SCREW AND THE SURGEON SUGGESTED THAT HE / THE SCRUB TEAM LOOK FOR THE SCREW. NOT REALISING THAT THE FIRST SCREW WAS STILL IN SITU, THE SURGEON THEN ATTEMPTED TO INSERT A DIFFERENT SCREW AND FOUND IT DIFFICULT TO INSERT. THE SURGEON SAID THAT THE SCREW WAS DIFFICULT TO INSERT AND ASKED IF THERE WAS A TOOL THAT COULD HELP. THE CLINICAL SUPPORT SPECIALIST, ALSO UNAWARE THAT THE SCREW WAS STILL IMPLANTED, SUGGESTED THAT A SHARP SHOOTER, AWL OR DRILL COULD POTENTIALLY HELP. THE SURGEON THEN USED AN AWL AND A HAMMER TO CREATE A PATHWAY FOR THE SECOND SCREW. HOWEVER, THIS ADVANCED THE FIRST SCREW PAST THE POINT ON THE CAGE WHERE IT SHOULD STOP. HE THEN USED A DRILL WHICH ADVANCED THE SCREW FURTHER. HE THEN PUT IN A SECOND SCREW WHICH PUS

  Patient problems: Spinal Cord Injury; Weakness

  MAUDE report 7147469 ↗
• InjuryApr 10, 2017Mechanical Problem; Migration or Expulsion of Device; Device Slipped; Mechanical Problem; Migration or Expulsion of Device

  IT WAS REPORTED THAT SCREW BACKED OUT, 4 MONTHS POST OP.

  Patient problems: Injury; No Information

  MAUDE report 6478086 ↗
• MalfunctionMar 30, 2017Mechanical Problem; Difficult to Remove; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT; SURGEON HAD DIFFICULTY REMOVING SCREWS FROM CAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6445573 ↗