INFINITY™ Occipitocervical Upper Thoracic System 3600215Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000473921), received between Jul 11, 2022 and May 15, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K163375); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR CERVI CAL C4-T3. IT WAS REPORTED THAT A SET SCREW WAS FOUND IN A X-RAY OF THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AN INFINITY SET SCREW IS VISIBLE ON AN X-RAY NOT IN THE TULIP OF A SCREW. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS NO ADDITIONAL SURGERY PERFORMED AND AT THIS TIME NO ADDITIONAL SURGERY IS PLANNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025756 ↗
• MalfunctionFeb 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURING REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING A ROUTINE CHECK-UP AT A 6-WEEK POST-OPERATIVE APPOINTMENT, TWO SET SCREWS FROM THE MULTI-AXIAL SCREW (MAS) WERE DISCOVERED TO HAVE POPPED OUT, AS REVEALED BY AN X-RAY. THE SET SCREWS AT C3 (RIGHT) AND T1 (LEFT) WERE IDENTIFIED AS HAVING POPPED OUT. THERE WERE NO REPORTED SYMPTOMS OR DISCOMFORT FROM THE PATIENT, AND NO INCIDENTS SUCH AS FALLS OR INJURIES WERE NOTED PRIOR TO THE DISCOVERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE WAS NO PLAN/SCHEDULE FOR THE REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372734 ↗
• MalfunctionJul 11, 2022Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING C1/C2 POSTERIOR FIXATION AND DECOMPRESSION. IT WAS REPORTED THAT USE OF 3 NM TOQUE LIMITING HANDLE ON 2 NM DRIVER SHAFT AND SET SCREWS RESULTED IN ROUNDING OF BOTH THE SET SCREWS AND THE DRIVER SHAFT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14974726 ↗
• MalfunctionJul 11, 2022Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING C1/C2 POSTERIOR FIXATION AND DECOMPRESSION. IT WAS REPORTED THAT USE OF 3 NM TOQUE LIMITING HANDLE ON 2 NM DRIVER SHAFT AND SET SCREWS RESULTED IN ROUNDING OF BOTH THE SET SCREWS AND THE DRIVER SHAFT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14974725 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163375. One submission often covers many models, so check the product and lot details in each record.

• Z-1410-2023 · Feb 16, 2023 · Open, Classified
  INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization and stabilization of spinal segment as an adjunct to fusion
• Z-1413-2023 · Feb 16, 2023 · Open, Classified
  INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion
• Z-1412-2023 · Feb 16, 2023 · Open, Classified
  INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization and stabilization of spinal segment as an adjunct to fusion
• Z-1409-2023 · Feb 16, 2023 · Open, Classified
  INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion
• Z-1411-2023 · Feb 16, 2023 · Open, Classified
  INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as