INFINITY™ Occipitocervical Upper Thoracic System G3603522Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169542280), received between Mar 25, 2020 and Nov 18, 2021 — classified as 2 injuries.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2021Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OPERATIVE DIAGNOSIS- C1/2 SUBLUXATION. INVOLVED IN THE C1/2 FUSION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, AFTER PLACEMENT, WHEN COMPRESSION WAS APPLIED, THE POSITION OF THE ROD CHANGED FROM THE SCREW HEAD, THE CONNECTOR WAS CHANGED. DURING SCREW INSERTION, THERE WAS BLEEDING (PROBABLY THE VENOUS PLEXUS) AND THE SCREW INSERTION WAS STOPPED. THE SCREW WAS CHANGED TO A SHORTER SCREW THAT DOES NOT REACH THE VA WHEN REINSERTION. PRODUCT WAS USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR LESS THAN 60 MINUTES. PATIENT WAS NOT HOSPITALIZED PROLONG. ON 2021-NOV-04, RECEIVED ADDITIONAL INFORMATION THAT HEMOSTASIS WAS PERFORMED WITH FLOSEAL AND GAUZE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12834485 ↗
• InjuryMar 25, 2020Migration; Migration

  ON (B)(6) 2020, THE DEVIATED SCREW (WHICH WAS IMPLANTED AT C5-C6 ON THE RIGHT SIDE) AND THE ROD WERE REMOVED ON THE SAME DAY THEY WERE IMPLANTED. ADDITIONAL SCREW INSERTION WAS NOT PERFORMED. ON (B)(6) 2020, HERNIATION WAS FOUND BETWEEN C5 AND C6. PARALYSIS WAS OBSERVED IN THE LOWER LIMBS. HENCE, A REVISION SURGERY WAS PERFORMED FOR THE HERNIATION. IN THE REVISION SURGERY, HERNIATION REMOVAL AND LAMINOPLASTY WERE PERFORMED. AFTER THAT, THE PARALYSIS IN THE PATIENT'S LOWER LIMBS WAS RESOLVED AND THERE WAS NO INFORMATION SUCH AS HEALTH DAMAGE IN THE PATIENT.

  Patient problems: Disc Impingement; Paralysis; Spinal Column Injury

  MAUDE report 9879480 ↗

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-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
• 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-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-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