Mesh 1007700Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517056337), received between Jan 14, 2025 and May 21, 2025 — classified as 3 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.

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.

• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 A PATIENT UNDERWENT AN ANTERIOR CERVICAL INTERBODY FUSION AT C5/6 AND C6/7 WITH AN ANTERIOR CERVICAL FIXATION PLATE AT C5 TO C7. ON (B)(6) 2024 PATIENT REPORTED NECK STIFFNESS AND LOW BACK PAIN THAT RADIATES INTO HIS LEGS ON (B)(6) 2024 PATIENT REPORTED NECK PAIN WHICH RADIATES INTO HIS ARMS, BALANCE PROBLEMS, HAND DYSFUNCTION AND GRIP WEAKNESS AND HEADACHES AS WELL AS CONTINUED LOW BACK PAIN REQUIRING INJECTION. ON (B)(6) 2025 PATIENT REQUIRED CONTINUING CERVICAL AND LUMBAR INJECTIONS TO MANAGE PAIN. ON (B)(6) 2025 RADIOGRAPHS AND CT IMAGES CONFIRMED C5-6 PSEUDOARTHROSIS. ON (B)(6) 2025 THE PATIENT IS EXPERIENCING PARESTHESIAS AND VERTIGO. NOTE VERTIGO WAS ONE OF MAIN PRE-OP SX. THAT WAS THOUGHT TO HAVE INITIALLY IMPROVEMENT POST OPERATIVELY WITH RETURN ~1 YEAR IN. THE PATIENT IS CURRENTLY BEING EVALUATED FOR A REVISION PROCEDURE.

  Patient problems: Back pain; Balance Problems; Headache; Muscle Weakness/Atrophy; Neck Pain; Neck Stiffness; Nonunion/Delayed-union Bone Fracture; Paresthesia; Vertigo

  MAUDE report 22066445 ↗
• InjuryFeb 18, 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 (B)(6) 2024 A PATIENT UNDERWENT A THREE LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION PROCEDURE AT C4/5, C5/6 AND C6/7. ON (B)(6) 2024 THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH C/O FEVER AND IDENTIFIED WITH A SYSTEMIC INFECTION AND TREATED WITH ANTIBIOTICS. NOTED AS RESOLVED ON (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 21393018 ↗
• InjuryJan 14, 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 (B)(6) 2024 A PATIENT UNDERWENT A THREE LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) PROCEDURE AT C3/4, C4/5 AND C5/6. ON (B)(6) 2024 THE PATIENT PRESENTED TO THE ER WITH SHORTNESS OF BREATH AND WAS DIAGNOSED WITH 2 PULMONARY EMBOLISMS AND DEEP VEIN THROMBOSIS (DVT). HE WAS ADMITTED AND TREATED AND SENT TO A REHABILITATION FACILITY. SIX WEEKS POST OP POST OPERATIVE THE PATIENT HAS REPORTEDLY RECOVERED BUT STILL ON MEDICATION.

  Patient problems: Adult Respiratory Distress Syndrome; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 21151595 ↗