Certex Spinal Fixation System X067-0022Recalls & reported problems
Xtant Medical Holdings, Inc. · CERTEX 3.5 X 14mm SCREW ASSEMBLY · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M697X06700221), received between Dec 21, 2023 and Dec 21, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (2 reports).
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
Most reported problems
Device problems
- Structural Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2023Structural Problem; Structural Problem
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2023. IT WAS REPORTED THAT TWO SYSTEM SCREW IMPLANTS WERE EXPLANTED AFTER PLACEMENT DURING A SURGICAL PROCEDURE DUE TO THE INTERNAL YOKE COMPONENT OF THE IMPLANTS NOT ALLOWING FOR INTRODUCTION OF SYSTEM RODS. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE SURGEON ELECTED TO PERFORM UNILATERAL FIXATION WITH THE SUCCESSFULLY PLACED SYSTEM SCREW IMPLANTS. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT IMPLANTS, WHICH WERE RECEIVED AT THE MANUFACTURER ON 12/18/2023 FOR COMPLAINT ASSESSMENT. THIS REPORT IS ASSOCIATED WITH MDR# 3005031160-2023-00025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18379942 ↗MalfunctionDec 21, 2023Structural Problem; Structural Problem
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2023. IT WAS REPORTED THAT TWO SYSTEM SCREW IMPLANTS WERE EXPLANTED AFTER PLACEMENT DURING A SURGICAL PROCEDURE DUE TO THE INTERNAL YOKE COMPONENT OF THE IMPLANTS NOT ALLOWING FOR INTRODUCTION OF SYSTEM RODS. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE SURGEON ELECTED TO PERFORM UNILATERAL FIXATION WITH THE SUCCESSFULLY PLACED SYSTEM SCREW IMPLANTS. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT IMPLANTS, WHICH WERE RECEIVED AT THE MANUFACTURER ON 12/18/2023 FOR COMPLAINT ASSESSMENT. THIS REPORT IS ASSOCIATED WITH MDR# 3005031160-2023-00026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18377650 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
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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