VERTEX® Reconstruction System 7755124Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994514509), received between Jun 27, 2017 and Nov 16, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- CHIN ON CHEST DEFORMITY INVOLVED IN THE POSTERIOR CERVICAL FUSION. ADDITION OF OCCIPITAL PLATE AND RODS TO EXISTING IMPLANT CONSTRUCT. LEVELS IM PLANTED- OCCIPUT TO T2. IT WAS REPORTED THAT POST-OPERATIVELY, THE OCCIPITAL ROD MECHANISM "FELL APART" SHORTLY AFTER SURGERY ON (B)(6) 2017. THEY DECIDED TO TREAT THE PATIENT WITH A HALO DEVICE RATHER THAN ANOTHER SURGERY TO REPLACE FAILED IMPLANTS. THE PATIENT EVENTUALLY HAD DIFFICULTY LOOKING STRAIGHT AHEAD, SO THEY SCHEDULED A REVISION OF THE OCCIPITAL RODS AND CORRECTION OF THE SAGITTAL DEFORMITY. THE PATIENT INCURRED A VASCULAR INJURY DURING THE REVISION ON (B)(6) 2021 AND THEY WERE UNABLE TO COMPLETE THE SURGERY. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT PATIENT HAD SUFFERED A MAJOR STROKE. IT HAS ALSO BEEN REPORTED TO THAT PATIENT HAD PASSED AROUND 6 PM ON (B)(6) 2021. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT AS PER A/P X-RAY IMAGE ON (B)(6) 2017, THE HINGE OF THE ROD ON THE RIGHT WAS DISCONNECTED. ON THE LATERAL X-RAY IMAGE OF (B)(6) 2017 THE PROXIMAL EXTENSION OF THE ROD THAT CONNECTS TO T

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12817992 ↗
• InjuryNov 16, 2017Break; Break

  THE PATIENT UNDERWENT OCCIPITAL AND CERVICAL FUSION DUE TO SKULL BASE DEPRESSION, THE ODONTOID SHIFT, ATLANTO-OCCIPITAL FUSION, EXISTENCE OF CERVICAL CURVATURE, ALONG THE COLUMN COULD BE, VERTEBRAL MARGIN AND FACET JOINT HYPERPLASIA SCLEROSIS, NO OBVIOUS NARROWING OF THE INTERVERTEBRAL SPACE, C2 ATTACHMENT MORPHOLOGICAL DISORDERS, VISIBLE BETWEEN THE LAMINA ON BOTH SIDES OF IRREGULAR BONE SHADOW, OPPRESSION DURAL SAC, SPINAL CANAL NARROWING, SLIGHT OFFSET IN ODONTOID POSITION, AND THE DISTANCE BETWEEN THE RIGHT LATERAL BLOCK PROOFING NARROW. THE ROD WAS COMPLETELY EXPLANTED IN THE REVISION SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7037680 ↗
• InjuryJun 27, 2017Break; Break

  PRE-OP DIAGNOSIS (REVISION SURGERY): CHRONIC WOUND DEHISCENCE, NON-UNION, BROKEN HARDWARE PROCEDURE: POSTERIOR CERVICAL FUSION FROM OCCIPUT TO C2. IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, ROD BROKE. PATIENT UNDERWENT REVISION SURGERY FOR REPLACEMENT OF BROKEN HARDWARE AS WELL AS FOR TREATMENT OF NON-UNION AND WOUND DEHISCENCE. BROKEN ROD WAS REPLACED.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 6669140 ↗