STALIF C ABS1540Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00815101029023), received between Aug 6, 2019 and Sep 19, 2019 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS RECEIVED (B)(6) 2017 INDICATING THE FOLLOWING: PATIENT PRESENTED 4-6 WEEKS POST OP COMPLAINING OF NECK PAIN. XRAYS CONFIRMED A C5 VERTEBRAL BODY FRACTURE. AT THE TIME OF INITIAL COMMUNICATION A REVISION HAD BEEN PERFORMED. INITIAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS NOT CONTRIBUTORILY. FURTHER COMMUNICATION WAS RECEIVED (B)(6) 2017 WHICH STATED THAT THE SURGEON DID FEEL THAT THE DEVICE MAY HAVE BEEN CONTRIBUTORILY TO THE FRACTURE OCCURRING AND THEREFORE THIS REPORT IS BEING SUBMITTED WITHIN 30 DAYS OF THAT COMMUNICATION. ORIGINAL SURGERY WAS COMPLETED ON (B)(6) 2017 FOR LEVELS C3-C5. THE PROCEDURE IMPLANTED 2 STALIF C-TI CAGES AND 6 STALIF C ABO SCREWS. IT WAS REPORTED THAT A HARDWARE FAILURE OCCURRED AS A RESULT OF THE VERTEBRAL BODY FRACTURE. POST FRACTURE THE SCREWS LOST PURCHASE AND THE IMPLANT BECAME LOOSE. IT IS BELIEVED THAT THIS CASE MAY HAVE BEEN AFFECTED BY OSTEOPOROSIS ALONG WITH AGGRESSIVE ENDPLATE PREPARATION. THE SURGEON FELT THAT A CRACK IN THE VERTEBRAL BODY MAY HAVE BEEN INITIATED BY THE HOLE FROM THE CASPAR PIN AND AFTER AGGRESSIVE ENDPLATE PREPARATION THIS CRACK COULD HAVE MIGRATED TO THE NEAREST IMPLANTED SCREW AND THE FRACTURE COU

  Patient problems: Neck Pain; Spinal Column Injury

  MAUDE report 9088037 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS RECEIVED (B)(6) 2017 INDICATING THE FOLLOWING: PATIENT PRESENTED 4-6 WEEKS POST OP COMPLAINING OF NECK PAIN. XRAYS CONFIRMED A C5 VERTEBRAL BODY FRACTURE. AT THE TIME OF INITIAL COMMUNICATION A REVISION HAD BEEN PERFORMED. INITIAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS NOT CONTRIBUTORILY. FURTHER COMMUNICATION WAS RECEIVED (B)(6) 2017 WHICH STATED THAT THE SURGEON DID FEEL THAT THE DEVICE MAY HAVE BEEN CONTRIBUTORILY TO THE FRACTURE OCCURRING AND THEREFORE THIS REPORT IS BEING SUBMITTED WITHIN 30 DAYS OF THAT COMMUNICATION. ORIGINAL SURGERY WAS COMPLETED ON (B)(6) 2017 FOR LEVELS C3-C5. THE PROCEDURE IMPLANTED 2 STALIF C-TI CAGES AND 6 STALIF C ABO SCREWS. IT WAS REPORTED THAT A HARDWARE FAILURE OCCURRED AS A RESULT OF THE VERTEBRAL BODY FRACTURE. POST FRACTURE THE SCREWS LOST PURCHASE AND THE IMPLANT BECAME LOOSE. IT IS BELIEVED THAT THIS CASE MAY HAVE BEEN AFFECTED BY OSTEOPOROSIS ALONG WITH AGGRESSIVE ENDPLATE PREPARATION. THE SURGEON FELT THAT A CRACK IN THE VERTEBRAL BODY MAY HAVE BEEN INITIATED BY THE HOLE FROM THE CASPAR PIN AND AFTER AGGRESSIVE ENDPLATE PREPARATION THIS CRACK COULD HAVE MIGRATED TO THE NEAREST IMPLANTED SCREW AND THE FRACTURE COU

  Patient problems: Neck Pain; Spinal Column Injury

  MAUDE report 9087871 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  FOLLOW UP 1 AUGUST 19, 2019: PATIENT'S ALLERGY TESTING HAS ALL COME BACK NEGATIVE FOR THE MATERIALS USED TO MANUFACTURE CENTINEL'S STALIF C CAGE AND ABO SCREWS. NO FURTHER DETAILS WERE PROVIDED BY THE PATIENT'S ALLERGIST. NO FURTHER INFORMATION WAS PROVIDED BY THE PATIENT. NO DIRECT LINK CAN BE ESTABLISHED BETWEEN THE PATIENT'S DESCRIBED SYMPTOMS AND THE CENTINEL SPINE DEVICES.

  Patient problems: Foreign Body Sensation in Eye; Swollen Glands

  MAUDE report 8865402 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  FOLLOW UP 1 AUGUST 19, 2019: PATIENT'S ALLERGY TESTING HAS ALL COME BACK NEGATIVE FOR THE MATERIALS USED TO MANUFACTURE CENTINEL'S STALIF C CAGE AND ABO SCREWS. NO FURTHER DETAILS WERE PROVIDED BY THE PATIENT'S ALLERGIST. NO FURTHER INFORMATION WAS PROVIDED BY THE PATIENT. NO DIRECT LINK CAN BE ESTABLISHED BETWEEN THE PATIENT'S DESCRIBED SYMPTOMS AND THE CENTINEL SPINE DEVICES.

  Patient problems: Foreign Body Sensation in Eye; Swollen Glands

  MAUDE report 8865314 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  FOLLOW UP 1 AUGUST 19, 2019: PATIENT'S ALLERGY TESTING HAS ALL COME BACK NEGATIVE FOR THE MATERIALS USED TO MANUFACTURE CENTINEL'S STALIF C CAGE AND ABO SCREWS. NO FURTHER DETAILS WERE PROVIDED BY THE PATIENT'S ALLERGIST. NO FURTHER INFORMATION WAS PROVIDED BY THE PATIENT. NO DIRECT LINK CAN BE ESTABLISHED BETWEEN THE PATIENT'S DESCRIBED SYMPTOMS AND THE CENTINEL SPINE DEVICES.

  Patient problems: Foreign Body Sensation in Eye; Swollen Glands

  MAUDE report 8865110 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  FOLLOW UP 1 AUGUST 19, 2019: PATIENT'S ALLERGY TESTING HAS ALL COME BACK NEGATIVE FOR THE MATERIALS USED TO MANUFACTURE CENTINEL'S STALIF C CAGE AND ABO SCREWS. NO FURTHER DETAILS WERE PROVIDED BY THE PATIENT'S ALLERGIST. NO FURTHER INFORMATION WAS PROVIDED BY THE PATIENT. NO DIRECT LINK CAN BE ESTABLISHED BETWEEN THE PATIENT'S DESCRIBED SYMPTOMS AND THE CENTINEL SPINE DEVICES.

  Patient problems: Foreign Body Sensation in Eye; Swollen Glands

  MAUDE report 8864997 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  FOLLOW UP 1 AUGUST 19, 2019: PATIENT'S ALLERGY TESTING HAS ALL COME BACK NEGATIVE FOR THE MATERIALS USED TO MANUFACTURE CENTINEL'S STALIF C CAGE AND ABO SCREWS. NO FURTHER DETAILS WERE PROVIDED BY THE PATIENT'S ALLERGIST. NO FURTHER INFORMATION WAS PROVIDED BY THE PATIENT. NO DIRECT LINK CAN BE ESTABLISHED BETWEEN THE PATIENT'S DESCRIBED SYMPTOMS AND THE CENTINEL SPINE DEVICES.

  Patient problems: Foreign Body Sensation in Eye; Swollen Glands

  MAUDE report 8864937 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  FOLLOW UP 1 AUGUST 19, 2019: PATIENT'S ALLERGY TESTING HAS ALL COME BACK NEGATIVE FOR THE MATERIALS USED TO MANUFACTURE CENTINEL'S STALIF C CAGE AND ABO SCREWS. NO FURTHER DETAILS WERE PROVIDED BY THE PATIENT'S ALLERGIST. NO FURTHER INFORMATION WAS PROVIDED BY THE PATIENT. NO DIRECT LINK CAN BE ESTABLISHED BETWEEN THE PATIENT'S DESCRIBED SYMPTOMS AND THE CENTINEL SPINE DEVICES.

  Patient problems: Foreign Body Sensation in Eye; Swollen Glands

  MAUDE report 8864811 ↗