VERTEX® Reconstruction System 6958714Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994355041), received between Nov 21, 2017 and Jul 15, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, REGULATORY BODY) REGARDING A PATIE NT IMPLANTED WITH SCREW HAVING SPINAL THERAPY FOR CERVICAL SPONDYLOTIC MYELOPATHY. IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL INCISION, DECOMPRESSION, BONE GRAFTING, FUSION AND INTERNAL FIXATION UNDER GENERAL ANESTHESIA, AND SCREWS WERE USED DURING THE OPERATION ON (B)(6) 2024. DURING THE STAY IN THE HOSPITAL, THE WOUND WAS NORMAL AND THE PATIENT WAS DISCHARGED WITHOUT REMOVING THE STITCHES. MEDICATION WAS NOT FOLLOWED PROPERLY BY PATIENT AND DID NOT MONITOR BLOOD SUGAR AFTER DISCHARGE. ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED AGAIN DUE TO POSTOPERATIVE WOUND INFECTION OF THE CERVICAL SPINE. PATIENT UNDERWENT DEBRIDEMENT, PERFUSION AND DRAINAGE FOR CERVICAL SPINE POSTOPERATIVE INFECTION AND THE PATIENT WAS DISCHARGED AFTER HEALING. EVENT OCCURRED DUE TO PATIENT'S OWN REASONS. LOOSENING OF INTERNAL FIXATION WAS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT POST-OPERATIVE INFECTION OCCURRED WAS NOT RELATED DUE TO REPORTED SCREW.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19738724 ↗
• InjuryNov 21, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED VIA A PATIENT CALL THAT THE PATIENT UNDERWENT SPINAL (CERVICAL/ THORACIC) FUSION SURGERY. POST-OP, SCREWS LOOSENING WERE REPORTED. THE PATIENT HAD 3 ADDITIONAL SURGERIES AND HAD PSEUDOARTHROSIS DOCUMENTED WHEN THE DEVICES WERE REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 7047838 ↗
• InjuryNov 21, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED VIA A PATIENT CALL THAT THE PATIENT UNDERWENT SPINAL (CERVICAL/ THORACIC) FUSION SURGERY. POST-OP, SCREWS LOOSENING WERE REPORTED. THE PATIENT HAD 3 ADDITIONAL SURGERIES AND HAD PSEUDOARTHROSIS DOCUMENTED WHEN THE DEVICES WERE REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 7047837 ↗