INFINITY™ Occipitocervical Upper Thoracic System G3602537Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169549487), received between Mar 9, 2021 and Mar 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2021Material Deformation; Scratched Material; Material Deformation; Scratched Material

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF DISLOCATION FRACTURE AT C7 INVOLVED IN C2-T3 FIXATION WAS PERFORMED AND C7 WAS SKIPPED FOR C7 DISLOCATION FRACTURE. LEVELS IMPLANTED- C2-T3. IT WAS REPORTED THAT AT INTRA-OP, THE OUTER SET SCREW STRIPPED WHEN THE CROSSLINK WAS FINALLY TIGHTENED. IMPLANT DID NOT BREAK. PRODUCT WAS USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. PRODUCT WAS NOT IMPLANTED IN THE PATIENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. PATIENT WAS NOT HOSPITALIZED PROLONG. THERE WERE NO PATIENT SYMPTOMS/COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ON 2021-MAR-04, RECEIVED ADDITIONAL INFORMATION THAT SET SCREW HOLE SCREW THREADS OF BOTH ARMS WERE SCRATCHED, UPPER ARM SET SCREW TIP SLIGHTLY SCRATCHED, AND HEX HOLE WAS STRIPPED. THE CENTER OF SCREW HEX HOLE WAS ALSO SLIGHTLY STRIPPED. BOTH THE DRIVERS WERE STRIPPED AT TIP. ONE OF THE DRIVER COULD NOT MATE WITH THE SAMPLE INFINITY SET SCREW M6. ANOTHER DRIVER COULD MATE WITH THE RETURNED IF ROD CROSSLINK L. IF TORQUE LIMITING HANDLE HAD NO OBVIOUS DEFECT IN APPEARANCE. THE HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11442401 ↗

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-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-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-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