VERTEX® Reconstruction System 6958724Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994354990), received between Nov 25, 2020 and Dec 30, 2024 — classified as 3 malfunctions.

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

• MalfunctionDec 30, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SCREWS AND A ROD USED IN CERVICAL SPINE TUMOR RESECTION AND INTERNAL FIXATION THERAPY FOR CERVICAL SPINE TUMOR. LEVELS IMPLANTED: C4-C7 IT WAS REPORTED THAT THE TWO SCREWS COULD NOT BE LOCKED AFTER THE SET SCREWS WERE INSTALLED. AFTER THE CROSSLINK ROD WAS KINKED ONCE, IT COULD NOT BE RESTORED, SO THE OPERATION WAS COMPLETED WITH A REPLACEMENT OF THE SAME MODEL OF THE MEDTRONIC PRODUCT. PATIENT SYMPTOMS ARE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ROD COULDN'T BE FOLDED BACK INTO THE PATIENT AFTER BEING BENT INTRA-OPERATIVE. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035398 ↗
• MalfunctionDec 28, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SCREWS AND A ROD USED IN CERVICAL SPINE TUMOR RESECTION AND INTERNAL FIXATION THERAPY FOR CERVICAL SPINE TUMOR. LEVELS IMPLANTED: C4-C7 IT WAS REPORTED THAT THE TWO SCREWS COULD NOT BE LOCKED AFTER THE SET SCREWS WERE INSTALLED. AFTER THE CROSSLINK ROD WAS KINKED ONCE, IT COULD NOT BE RESTORED, SO THE OPERATION WAS COMPLETED WITH A REPLACEMENT OF THE SAME MODEL OF THE MEDTRONIC PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ROD COULDN'T BE FOLDED BACK INTO THE PATIENT AFTER BEING BENT INTRA-OP ERATIVE. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031435 ↗
• MalfunctionNov 25, 2020Break; Material Disintegration; Break; Material Disintegration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF CERVICAL DEGENERATION. UNDERGOING A POSTERIOR CERVICAL DECOMPRESSION AND INTERNAL FIXATION PROCEDURE. IT WAS REPORTED THAT DURING THE SURGERY, THE UNIVERSAL SCREW WAS BROKEN AND DISINTEGRATED, SO IT WAS REMOVED AND REPLACED IMMEDIATELY. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. NO PATIENT SYMPTOMS/COMPLICATIONS REPORTED. THE PRODUCT WILL BE RETURNED AND WAS REPLACED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10903806 ↗