NA 421.527Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587050591), received between Aug 19, 2020 and Aug 19, 2020 — 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.

• 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 PROCEDURE DUE TO TRIGEMINAL NEURALGIA. PATIENT WAS IMPLANTED WITH AN UNKNOWN MESH PLATES AND BURR HOLE COVER. THERE WAS A SURGICAL TIME OF ONE-HUNDRED THIRTY-FIVE (135) MINUTES. THERE WAS NO INTRA-OPERATIVE COMPLICATION. THE HEALING STATUS AND RADIOGRAPHIC OUTCOME AT THE FINAL FOLLOW-UP WAS THAT THE SURGERY HELPED FOR ABOUT ONE YEAR, BUT PAIN HAS RECURRED. THREE (3) WEEKS AGO, THE PATIENT HAD A SEVERE RECURRENCE, AND REQUIRED MEDICATIONS, AND HAD MILD NUMBNESS OF THE FACE IN THE V2/V3 REGION AT 80%. THERE WAS NO POST-OPERATIVE COMPLICATION PRESENTED. THE PATIENT DID NOT UNDERGO RE-OPERATION. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Hypoesthesia; No Code Available; Pain

  MAUDE report 10427134 ↗
• 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 PROCEDURE. PATIENT WAS IMPLANTED WITH AN UNKNOWN MESH PLATES AND BURR HOLE COVER. PATIENT REPORTEDLY HAD RECURRENCE OF PAIN WITHIN 8 MONTHS WHICH THEN DEVELOPED TO LEFT-SIDED TRIGEMINAL NEURALGIA PAIN POST-OPERATIVELY. ALSO, PATIENT REPORTED OCCASIONAL EYE TWITCHING. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10425342 ↗
• 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 PROCEDURE DUE TO TRIGEMINAL NEURALGIA. THE PATIENT WAS IMPLANTED WITH BURR HOLE COVER AND AN UNKNOWN MESH PLATES. THERE WAS A SURGICAL TIME OF 135 MINUTES. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THE DURATION OF FOLLOW UP WAS OF 1751 DAYS. THE HEALING STATUS/ RADIOGRAPHIC OUTCOMES AT FINAL FOLLOW-UP WAS THAT THE PATIENT REPORTS DELAYED FACIAL NUMBNESS AFTER GAMMA KNIFE AND REPORTED 100% IMPROVEMENT. THE PATIENT WAS PLEASED WITH RESULTS OF GAMMA KNIFE BUT HER PAIN RECURRED TWO WEEKS AGO, BUT SHE FEELS THIS IS ASSOCIATED WITH NASAL DRAINAGE. LEFT MEDIAL SPHENOID ENCEPHALOCELE - STABLE AFTER MIDDLE FOSSA CRANIOTOMY. THE PATIENT UNDERWENT REOPERATION BECAUSE OF THE LEFT FRONTAL/TEMPORAL CRANIOTOMY FOR REPAIR OF MENINGOENCEPHALOCELE AND GAMMA KNIFE RADIOSURGERY FOR RIGHT-SIDED TRIGEMINAL NEURALGIA. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10424703 ↗