NA 421.526Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587050584), received between Aug 19, 2020 and Aug 19, 2020 — 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A MICROVASCULAR DECOMPRESSION (MVD) PROCEDURE DUE TO TRIGEMINAL NEURALGIA. THE PATIENT WAS IMPLANTED WITH BURR HOLE COVER AND AN UNKNOWN MESH PLATES. THERE WAS A SURGICAL TIME OF ONE-HUNDRED FORTY-SIX (146) MINUTES. THERE WERE INTRA-OPERATIVE COMPLICATIONS. AS THE SURGEON TURNED UP TOWARDS THE TRIGEMINAL NERVE AND THEN HE ENCOUNTERED SIGNIFICANT VENOUS BLEEDING FROM A BRIDGING VEIN PROXIMAL TO THE PETROSAL DANDY VEIN. IT WAS PRESUMED THAT THERE MUST BE A LARGE PETROSAL VEIN BRIDGING VEIN FROM THE CEREBELLUM TO THE PETROSAL SINUS, BUT PHYSICIAN COULD NOT SEE IT, AND THEREFORE IT WAS PACKED THAT AREA WITH GELFOAM. THE SURGEON HAD TO WAIT SEVERAL MINUTES FOR HEMOSTASIS AND AS THE VENOUS BLEEDING STOPPED, THE PROCEDURE CONTINUED. THE DURATION OF FOLLOW UP WAS OF 1972 DAYS. THE HEALING STATUS/RADIOGRAPHIC OUTCOMES AT FINAL FOLLOW-UP WAS THAT THE PATIENT POST PROCEDURE REPORTED 100% RELIEF TO PAIN. IT WAS ALSO REPORTED THAT PATIENT HAD 50% NUMBNESS IN THE RIGHT TONGUE POST MVD WITH SHARP SHOOTING PAIN IN THE RIGHT V2/V3 RETURNED ABOUT NINE (9) MONTHS AGO. THERE WERE NO POST-OPERATIVES COMPLICATION PRESENTED. THE PATIENT DID N

  Patient problems: Hypoesthesia; No Code Available; Pain

  MAUDE report 10426923 ↗