Skip to content

CoRoent 6421050Recalls & reported problems

Nuvasive, Inc. · CoRoent® XLW Ti, 10x22x50mm 10° · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517310972), received between Mar 14, 2017 and Mar 14, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Malposition of Device1

Patient problems

  • Blood Loss1
  • Damage to Ligament(s)1
  • Laceration(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 14, 2017Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2017 A (B)(6) FEMALE PATIENT UNDERWENT A LATERAL INTERBODY REPLACEMENT WITH POSTERIOR FIXATION PROCEDURE AT L4/5. DURING THE PLACEMENT OF CAGE THE ALL WAS BREACHED WHICH RESULTED IN ANTERIOR PLACEMENT AND A 1000 ML BLOOD LOSS. THE BLEEDING WAS STOPPED AND IMPLANT WAS LEFT IN-SITU. THE REMAINING SURGERY WAS POSTPONED AND RESCHEDULED FOR A LATER DATE.

    Patient problems: Blood Loss; Damage to Ligament(s); Laceration(s)

    MAUDE report 6403189 ↗

Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices

All SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.