Mesh 1007699Recalls & reported problems
Nuvasive, Inc. · Mesh, 16x12mm · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517056320), received between Oct 18, 2024 and May 23, 2025 — classified as 2 injuries.
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 Problem2
Patient problems
- Dysphagia/ Odynophagia2
- Neck Pain1
- Pain1
- Paresthesia1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2025Adverse 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 PMCF STUDY, THE REPORT IDENTIFIED THAT ON MAR 05, 2024 A PATIENT UNDERWENT A THREE LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION AT C4/5, C5/6 AND C6/7 WITH ANTERIOR FIXATION C4-C7. ON MAR 20, 2024 THE PATIENT PRESENTED WITH RECURRENT SKULL PAIN EQUAL IN SEVERITY AS PRIOR TO SURGERY. SHE ALSO REPORTS MILD BUT RESIDUAL BASE OF NECK AND SHOULDER PAIN AS WELL AS PERSISTENT DYSPHAGIA CAUSING WEIGHT LOSS. ON JUNE 03, 2024 THE PATIENT CONTINUES TO HAVE DYSPHAGIA AND WAS REFERRED TO ENT FOR EVALUATION FOR UNDERLYING ESOPHAGEAL ISSUES. ON SEPT 04, 2024 THE PATIENT REPORTED CONTINUED DYSPHAGIA, LEFT TRAP/SHOULDER AND NECK PAIN AS WELL AS PARESTHESIA. STARTED PHYSICAL THERAPY AND NARCOTICS FOR DYSPHAGIA AND PAIN MANAGEMENT FOR CERVICAL PAIN. ON MAR 24, 2025 THE PATIENT REPORTED WITH NO CHANGE IN SITUATION AND CONTINUING WITH MEDICATIONS FOR PAIN MANAGEMENT.
Patient problems: Dysphagia/ Odynophagia; Neck Pain; Pain; Paresthesia
MAUDE report 22078702 ↗InjuryOct 18, 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 PMCF STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2024 A PATIENT UNDERWENT A TWO LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION PROCEDURE AT C4/5 AND C5/6. ON (B)(6) 2024 THE PATIENT COMPLAINS OF SUBSTANTIAL DYSPHAGIA POST-OPERATIVELY. PATIENT ADMITTED TO HOSPITAL FOR IV STEROIDS AND FLUIDS SINCE THE PATIENT HAS NOT BEEN ABLE TO EAT OR DRINK VERY WELL. AT 2 WK FOLLOW-UP, DYSPHAGIA IS IMPROVING, BUT NOT COMPLETELY RESOLVED.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 20487045 ↗
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- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- 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.