INFINITY™ Occipitocervical Upper Thoracic System G3600215Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000474010), received between Sep 20, 2024 and Aug 14, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

• InjuryAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C3-TH1 POSTERIOR FIXATION THERAPY FOR C5/6 FRACTURE. IT WAS REPORTED THAT THE SET SCREW DETACHED TWO WEEKS AFTER SURGERY WITHOUT CAUSING SYMPTOMS. SUBSEQUENT MONITORING REVEALED TWO ADDITIONAL DISLODGEMENTS, LEADING TO A PLANNED REPEAT SURGERY (ON (B)(6) 2025). THE PHYSICIAN ATTRIBUTED THE ISSUE TO A PRODUCT DEFECT, NOT MISUSE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. RE-OPERATION FOR REPLACING THE ROD AND SET SCREW WAS PERFORMED. EVEN THE PART WHERE THE SET SCREW WAS NOT LOOSENED COULD BE REMOVED EASILY (WITHOUT APPLYING MORE FORCE THAN USUAL). REOPERATION WAS PERFORMED DUE TO SET SCREW DISLODGEMENT AFTER THE INITIAL SURGERY OF (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809150 ↗
• InjuryAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WERE TOTALLY 8 PRODUCTS WERE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809127 ↗
• InjuryAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WERE TOTALLY 8 PRODUCTS WERE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809108 ↗
• InjurySep 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS CERVICAL SPONDYLOTIC MYELOPATHY (CSM). IT WAS REPORTED THAT, SETSCREW WAS DISLODGED POST-OPERATIVELY. PATIENT EXPERIENCED PAIN IN THE CERVICAL SPINE. REVISION SURGERY WAS PERFORMED AND THE SET SCREW WAS RE-INSERTED AND THE DEVICE WAS SECURED TO C2 (PREVIOUSLY FIXED AT C3/7). DURING THE INITIAL SURGERY, ONE ROD WAS CUT INTO TWO AND IMPLANTED. THERE ARE NO DEFECTS IN THE ROD ITSELF. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain

  MAUDE report 20265021 ↗

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-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-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