Vertex Reconstruction System G7755275Recalls & reported problems

Medtronic Sofamor Danek, Inc. · ROD G7755275 PRE-BENT CCM 3.5 X 200MM · Class 2 · Implant

All models of VERTEX Reconstruction System (34)

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994666970), received between Jan 21, 2019 and Jul 15, 2024 — classified as 2 injuries.

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

Adverse Event Without Identified Device or Use Problem2

Patient problems

Pressure Sore/Ulcer1
Stenosis1
Unspecified Infection1

Recent adverse event reports

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

InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED SCREW HAVING O-C4 FIXATION THERAPY FOR DECUBITUS INFECTION. IT WAS REPORTED THAT THE SET SCREW OF THE RIGHT OCCIPITAL PLATE AND THE SET SCREW OF THE C4 SCREW DISLODGED. THE ROD WAS SEPARATED FROM THE HEAD OF THE OCCIPITAL BONE PLATE, CAUSING BEDSORES IN THE OCCIPITAL REGION. IN ADDITION, THERE WAS AN INFECTION. THIS EVENT WAS REPEAT SURGERY BECAUSE THERE WAS DEBRIDEMENT AND REMOVAL DUE TO DECUBITUS INFECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE REVISION SURGERY OCCURRED DUE TO INFECTION WAS RELATED TO THE PRODUCTS REPORTED AND THERE WAS NO MALFUNCTION ASSOCIATED WITH THE ROD.
Patient problems: Pressure Sore/Ulcer; Unspecified Infection
MAUDE report 19742689 ↗
InjuryJan 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: CERVICAL TUMOR PROCEDURE: OCCIPITAL BONE POSTERIOR CERVICAL FUSION LEVELS IMPLANTED: O-T3 IT WAS OBSERVED THAT POST-OP, AIRWAY STENOSIS OCCURRED AFTER THE REPORTED PRODUCT WAS FIXED WITH AN OC ANGLE DEFECT AND PATIENT WAS UNABLE TO BREATH, AND TRACHEOTOMY WAS PERFORMED. THERE WERE NO MALFUNCTIONS WITH THE ROD OR OTHER IMPLANTS.FOR FIXATION AND REPLACING THE ROD, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. STENOSIS OCCURRED DUE TO THE OVERALL ALIGNMENT OF THE ROD.
Patient problems: Stenosis
MAUDE report 8264669 ↗

Device details

UDI-DI	`00613994666970`
Brand	Vertex Reconstruction System
Model	G7755275
Company	Medtronic Sofamor Danek, Inc.
Product code	KWP · APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Class	Class 2
FDA submission	K180851
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
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.

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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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