VERTEX® Reconstruction System 6900240Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00681490885843), received between Jul 4, 2017 and Mar 5, 2025 — classified as 4 injuries.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM REGULATORY BODY (RB), HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED FOR ROBOT-ASSISTED SKULL TRACTION POSTERIOR CERVICAL APPROACH ATLANTOAXIAL REDUCTION AND INTERNAL FIXATION WAS PERFORMED FOR TREATMENT OF AXIS FRACTURE. IT WAS REPORTED THAT AFTER THE OPERATION, WOUND INFECTION OCCURRED ON (B)(6) 2024. DEBRIDEMENT, PERFUSION, FLUSHING AND DRAINAGE OPERATION WAS PERFORMED ON (B)(6) 2024.  THE CAUSE OF INFECTION WAS DUE TO PATIENT'S CONDITION. THERE WAS NO DEVICE MALFUNCTION REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WAS NO MALFUNCTION WITH REPORTED PRODUCTS AND THEY ARE NOT EXPLANTED, STILL REMAINS IN PATIENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21524281 ↗
• InjuryJul 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM REGULATORY BODY, HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. ON (B)(6) 2024, HE UNDERWENT POSTERIOR CERVICAL INCISION, DECOMPRESSION, BONE GRAFTING, FUSION AND INTERNAL FIXATION UNDER GENERAL ANESTHESIA. ROD AND PEDICLE SCREWS WERE USED DURING THE OPERATION. DURING THE HOSPITAL STAY, THE WOUND WAS NORMAL AND THE PATIENT WAS DISCHARGED WITHOUT REMOVING THE STITCHES. ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED AGAIN DUE TO POSTOPERATIVE INFECTION OF THE CERVICAL SPINE. DEBRIDEMENT WAS PERFORMED AND THE PATIENT WAS DISCHARGED AFTER RECOVERY. HE DID NOT FOLLOW THE DOCTOR'S INSTRUCTIONS TO CHANGE THE MEDICINE REGULARLY AT THE MEDICAL INSTITUTION, BUT CHANGED THE MEDICINE AT HOME ON HIS OWN, AND DID NOT HAVE A STRONG SENSE OF STERILITY. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE SECOND TIME AND UNDERWENT DEBRIDEMENT, PERFUSION AND DRAINAGE FOR POSTOPERATIVE INFECTION OF THE CERVICAL SPINE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19740146 ↗
• InjuryJul 4, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY ON (B)(6) 2016. POST-OP, ON AN UNKNOWN DATE, THE RODS BROKE. HENCE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 IN WHICH RODS WERE COMPLETELY EXPLANTED.

  Patient problems: No Code Available

  MAUDE report 6685248 ↗
• InjuryJul 4, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY ON (B)(6) 2016. POST-OP, ON AN UNKNOWN DATE, THE RODS BROKE. HENCE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 IN WHICH RODS WERE COMPLETELY EXPLANTED.

  Patient problems: No Code Available

  MAUDE report 6685246 ↗