VERTEX® Reconstruction System G7755124Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994667199), received between Sep 27, 2017 and Nov 23, 2023 — 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 23, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR POSTERIOR OCCIPITOCERVICAL FUSION. PROCEDURE PERFORMED WAS POSTERIOR OCCIPITOCERVICAL FUSION WAS PERFORMED ON (B)(6) DUE TO C2 METASTASIS. LEVEL AT WHICH IMPLANT WAS PERFORMED O/C3. IT WAS REPORTED THAT THE ROD ALIGNMENT CHANGED POSTOPERATIVELY AND THE O-C2 ANGLE CHANGED, RESULTING IN A REOPERATION. DATE OF INITIAL SURGERY ON (B)(6) 2023 THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18202922 ↗
• InjuryAug 8, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR CEREBRAL PALSY. PROCEDURE PERFORMED WAS POSTERIOR CERVICAL SPINE FUSION. IT WAS REPORTED THAT THE AFTER C2 TO C6 WERE ALREADY FIXED WITH JJ'S SYNAPSES (ABOUT 10 YEARS AGO), DEPLOYMENT SURGERY WAS PERFORMED IN (B)(6) 2023 USING A CRANIAL PLATE (VS). AFTERWARD, THERE WAS A POSSIBILITY THAT SOME KIND OF MALFUNCTION OCCURRED WITH THE ADJUSTABLE ROD. HENCE, IT WAS CONFIRMED BY PERFORMING A REOPERATION. THE JOINT OF THE ADJUSTABLE ROD BROKE, AND IT WAS REPLACED WITH A PREVENT ROD (CCM) (ONLY THE RIGHT SIDE). THE INVOLUNTARY MOVEMENT OF CEREBRAL PALSY WAS ACCOMPANIED BY A LOAD APPLIED TO THE ROD, WHICH LED TO THE BREAKAGE OF THE ROD JOINT. PROCEDURE WAS PERFORMED FOR THE REMOVAL OF BROKEN ROD. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. MDT PRODUCT WAS NOT USED IN THE INITIAL SURGERY. THERE WAS NO DELAY IN THE OVERALL PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477905 ↗
• InjurySep 27, 2017Break; Break

  THE PATIENT UNDERWENT POSTERIOR CERVICAL FUSION AT OC-C6. POST-OP, THE PATIENT COMPLAINED OF PAIN AT CERVICAL. PATIENT UNDERWENT X-RAY WHICH REVEALED BREAKAGE OF CONNECTOR PART OF THE ADJUSTABLE ROD AT OC-C2. THIS CAUSED PROTRUSION OF ROD AND PAIN. THE BROKEN ROD WAS SCHEDULED TO BE REMOVED ON (B)(6) 2017. NO INFORMATION REGARDING REVISION SURGERY WAS MADE AVAILABLE.

  Patient problems: Neck Pain

  MAUDE report 6897711 ↗