Mesh 1007696Recalls & reported problems
Nuvasive, Inc. · Mesh, 16x9mm · 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 00887517056306), received between Dec 13, 2024 and Dec 13, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Dysphagia/ Odynophagia1
- Pain1
- Respiratory Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE CERVICAL INTERBODY PCMF STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2024 A PATIENT UNDERWENT A TWO LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION PROCEDURE AT C3/4 AND C4/5 AFTER WHICH THE PATIENT WAS OBTUNDED AND GIVEN NALAXONE AND PLACED ON BIPAP DUE TO HYPERCARBIC RESPIRATORY FAILURE AND TRANSFERRED TO ICU. ON (B)(6) 2024 SHE WAS EVALUATED BY SLP DUE TO INABILITY TO SWALLOW DUE TO PAIN, COUGHING AND CHOKING REQUIRING STEROIDS TO DECREASE SWELLING LATER DISCHARGED ON FULL LIQUID DIET AND CONSIDERED DYSPHAGIA.
Patient problems: Dysphagia/ Odynophagia; Pain; Respiratory Arrest
MAUDE report 20928188 ↗
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- GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.