VERTEX® Reconstruction System 7002527Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074175065), received between Sep 19, 2019 and Apr 6, 2020 — classified as 3 malfunctions.

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.

• MalfunctionApr 6, 2020Break; Break

  PREOPERATIVE DIAGNOSIS: SPINAL TUMORS; INCOMPLETE PARAPLEGIA; SYSTEMIC EXTENSIVE SECONDARY MALIGNANT TUMORS; PERSONAL HISTORY OF BREAST MALIGNANCIES; BILATERAL PLEURAL EFFUSION; LEFT LOWER ATELECTASIS; GALLBLADDER POLYPS; HYPOPROTEINEMIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL AND THORACIC FUSION SURGERY. INTRA-OP, THE IMPLANTED PRODUCT (CROSSLINK) WAS FRACTURED/BROKE AND COULD NOT BE USED NORMALLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9927358 ↗
• MalfunctionNov 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL FUSION DUE TO CERVICAL DEGENERATION AND SPONDYLOSIS. INTRA-OP, THE CROSSLINK BROKE. THE CROSSLINK WAS COMPLETELY EXPLANTED AFTER IT BROKE, WITH NO BROKEN FRAGMENTS OF THE PRODUCT REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9368365 ↗
• MalfunctionSep 19, 2019Crack; Crack

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR CERVICAL FIXATION AND FUSION SURGERY DUE TO CERVICAL VERTEBRA DEGENERATION. INTRA-OP, DURING SURGICAL IMPLANTATION, THE CROSSLINK CRACKED AT THE PLACE WHERE IT LOCKS; HENCE, THIS CRACKED CROSSLINK WAS REPLACED WITH A NEW CROSSLINK. NO FRAGMENT OF THE CRACKED CROSSLINK REMAINED INSIDE THE PATIENT. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9085596 ↗