INFINITY™ Occipitocervical Upper Thoracic System G3600216Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SET SCREW PK G3600216 SET SCREW 4PK · Class 2 · Implant

All models of INFINITY Occipitocervical Upper Thoracic System (35)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20763000960005), received between Jul 6, 2026 and Jul 6, 2026 — classified as 1 injury.

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

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Dislodged or Dislocated1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

InjuryJul 6, 2026Device Dislodged or Dislocated
ON (B)(6) 2026 MPXR (B)(4) (REP, HCP, FOR): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REOPERATION C1/2 POSTERIOR FIXATION, BONE GRAFTING FOR C1 INSTABILITY DUE TO TRAUMA. IT WAS REPORTED THAT PATIENT HAD POSTOPERATIVE SET-SCREW DISLODGEMENT. THE RIGHT C1 SET SCREW DISENGAGED POSTOPERATIVELY, AND LOOSENING OF THE RIGHT SCREW (C1/2) WAS CONFIRMED; THEREFORE, THE SIZE WAS CHANGED AND REFIXATION WAS PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25713634 ↗

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-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-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

Device details

UDI-DI	`20763000960005`
Brand	INFINITY™ Occipitocervical Upper Thoracic System
Model	G3600216
Company	Medtronic Sofamor Danek, Inc.
Product code	KWP · APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Class	Class 2
FDA submission	K163375
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Mar 24, 2025

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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