Certex Spinal Fixation System X067-0470Recalls & reported problems
Xtant Medical Holdings, Inc. · COUNTER TORQUE SLEEVE, ASSEMBLY · Class 2
Data updated Oct 18, 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 M697X06704701), received between Aug 9, 2021 and Nov 30, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Break1
- Material Fragmentation1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2022Material Fragmentation; Material Fragmentation
THE MANUFACTURER WAS MADE AWARE OF AN INSTRUMENT MALFUNCTION ON 11/04/2022. IT WAS REPORTED THAT A DISTAL TINE OF A SYSTEM COUNTER TORQUE SLEEVE FRACTURED WHILE BEING USED DURING A SURGICAL PROCEDURE ON (B)(6) 2022. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAYS IN TREATMENT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 11/17/2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15886869 ↗MalfunctionAug 9, 2021Break; Break
THE COMPANY RECEIVED NOTIFICATION ON 7/13/2021 OF A SYSTEM COUNTER TORQUE SLEEVE THAT WAS REQUESTED TO BE REPLACED DUE TO AN INSTRUMENT MALFUNCTION. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS NOT RECEIVED AT THE COMPANY FOR COMPLAINT ASSESSMENT. NO OTHER INFORMATION REGARDING THE SURGICAL PROCEDURE OR INSTRUMENT DEFICIENCY WAS PROVIDED. REPEATED ATTEMPTS TO COLLECT COMPLAINT INCIDENT INFORMATION AND RETURN OF THE COMPLAINT INSTRUMENT WERE UNSUCCESSFUL.
Patient problems: Insufficient Information
MAUDE report 12298520 ↗
Other Posterior cervical screw system devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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