INFINITY™ Occipitocervical Upper Thoracic System 3603518Recalls & reported problems

Medtronic Sofamor Danek, Inc. · MULTI AXIAL SCREW 3603518 3.5 X 18MM · 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: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169554429), received between Feb 26, 2025 and Feb 26, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Break1

Patient problems

Pain1

Recent adverse event reports

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

MalfunctionFeb 26, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE STATING PROCEDURE/TECHNIQUE PERFORMED WAS C3-7 POSTERIOR CERVICAL FUSION. NO FURTHER COMPLICATIONS REPORTED.
Patient problems: Pain
MAUDE report 21466218 ↗

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-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-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-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

Device details

UDI-DI	`00643169554429`
Brand	INFINITY™ Occipitocervical Upper Thoracic System
Model	3603518
Company	Medtronic Sofamor Danek, Inc.
Product code	NKG · Orthosis, cervical pedicle screw spinal fixation
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	Sep 11, 2024

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.

Other Orthosis, cervical pedicle screw spinal fixation devices

INFINITY™ Occipitocervical Upper Thoracic System 3604026
Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation
2 recalls1 report
CONNECTOR 79-2003
Orthofix US LLC · Posterior cervical screw system
1 recall0 reports
INFINITY™ Occipitocervical Upper Thoracic System 360PT4022
Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation
1 recall0 reports
CONNECTOR 79-2002
Orthofix US LLC · Posterior cervical screw system
1 recall0 reports
INFINITY™ Occipitocervical Upper Thoracic System 3604532
Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation
1 recall0 reports
INFINITY™ Occipitocervical Upper Thoracic System 3604024
Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation
1 recall0 reports
OASYS 48551000
Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation
45 reports
YUKON OCT Spinal System 7601-05030
VB Spine LLC · Orthosis, cervical pedicle screw spinal fixation
15 reports

All Orthosis, cervical pedicle screw spinal fixation 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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