NA 421.528Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10887587050607), received between Dec 19, 2018 and Jul 20, 2022 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Slipped” (1 report).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2022Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2022 HE HAD A PATIENT NEEDING A CRANIAL PLATE REMOVAL WHERE HE REMOVED SYNTHES LOW PROFILE PLATES AND SCREWS. SEVERAL SCREWS WERE LOOSE IN THE SKULL AND CAUSING THE PATIENT PAIN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) TI LOW PRO NEURO BURR HOLE COVER 24 DIA. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 15067857 ↗
• 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. PATIENT WAS IMPLANTED WITH UNKNOWN MESH PLATES AND BURR HOLE COVER. THERE WAS A SURGICAL TIME OF EIGHTY-NINE (89) MINUTES. THERE WAS NO INTRA-OPERATIVE COMPLICATION. THE HEALING STATUS AND RADIOGRAPHIC OUTCOME AT THE FINAL FOLLOW-UP REPORTED THE PAIN RETURNED ABOUT SIX (6) MONTHS AFTER MVD. THERE WAS NO POSTOPERATIVE COMPLICATION. THE PATIENT DID NOT UNDERGO RE-OPERATION. THIS REPORT IS FOR A TITANIUM (TI) LOW PROFILE NEURO BURR HOLE COVER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10427177 ↗
• 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 TITANIUM LOW PROFILE NEURO BURR HOLE COVER. THERE WAS A SURGICAL TIME OF 117 MINUTES. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THE DURATION OF FOLLOW UP WAS OF 468 DAYS. THE HEALING STATUS/ RADIOGRAPHIC OUTCOMES AT FINAL FOLLOW-UP WAS THAT THE PATIENT REPORTED 100% PAIN RELIEF AFTER SURGERY, BUT HER PAIN RECURRED. THERE WERE NO POST-OPERATIVES COMPLICATION PRESENTED. THE PATIENT UNDERWENT REOPERATION DUE TO GAMMA KNIFE SRS FOR RECURRENT TRIGEMINAL NEURALGIA. 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 2 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10426932 ↗
• 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. POSTOPERATIVELY, PATIENT HAD NECK PAIN AND HEADACHE. DIAGNOSED WITH CHEMICAL MENINGITIS, PATIENT WAS ADMITTED TO THE HOSPITAL FOR LP AND THE POSTOPERATIVE COMPLICATIONS WERE RESOLVED. 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: Headache; No Code Available; Pain

  MAUDE report 10426691 ↗
• 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 UNKNOWN MESH PLATES AND BURR HOLE COVER. THERE WAS A SURGICAL TIME OF 136 MINUTES. THERE WAS NO INTRA-OPERATIVE COMPLICATION. THE HEALING STATUS AND RADIOGRAPHIC OUTCOME AT THE FINAL FOLLOW-UP HAD RECURRENCE OF PAIN (SHARP SHOOTING EPISODES), PROCEEDED WITH GLYCEROL RHIZOTOMY. THERE WAS NO POSTOPERATIVE COMPLICATION. THE PATIENT DID UNDERWENT RE-OPERATION DUE TO RIGHT GLYCEROL RHIZOTOMY FOR TRIGEMINAL NEURALGIA. 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: No Code Available; Pain

  MAUDE report 10426664 ↗
• 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 (100) MINUTES. THERE WAS NO INTRA-OPERATIVE COMPLICATION. THE HEALING STATUS AND RADIOGRAPHIC OUTCOME AT THE FINAL FOLLOW-UP WAS THAT THE PATIENT DID WELL POST-SURGERY, BUT HAD GRADUAL RETURN OF PAIN, DOING WELL AFTER SECOND SURGERY AND REPORTS IMPROVEMENT IN PAIN. THERE WAS NO POST-OPERATIVE COMPLICATION PRESENTED. THE PATIENT UNDERGO RE-DO MICROVASCULAR DECOMPRESSION. 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: No Code Available; Pain

  MAUDE report 10426380 ↗
• 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 GLOSSOPHARYNGEAL NEURALGIA. THE PATIENT WAS IMPLANTED WITH TITANIUM LOW PROFILE NEURO BURR HOLE COVER AND MESH PLATES. THERE WAS A SURGICAL TIME OF 126 MINUTES. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THE PATIENT FOLLOW-UP OCCURRED 1221 DAYS AFTER THE PROCEDURE. THE HEALING STATUS/RADIOGRAPHIC OUTCOMES AT FINAL FOLLOW-UP WAS THAT THE PATIENT HAD THREE (3) YEARS OF PAIN RELIEF FOLLOWING THE PROCEDURE, BUT THE PAIN THEN RECURRED. THE PATIENT THEN SUCCESSFULLY COMPLETED A SECOND MVD PROCEDURE. THERE WERE NO POST-OPERATIVE COMPLICATIONS PRESENTED. THE PATIENT UNDERWENT REOPERATION DUE TO REPEAT MICROVASCULAR DECOMPRESSION (MVD). 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: Pain

  MAUDE report 10426092 ↗
• 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 PLATES AND BURR HOLE COVER. THERE WAS NO POST OPERATIVE COMPLICATION PRESENTED. PATIENT WAS DOING WELL AFTER SURGERY BUT REPORTED SUDDEN RECURRENCE OF PAIN 2 WEEKS PRIOR TO VISIT. 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: No Code Available; Pain

  MAUDE report 10425975 ↗
• 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 HAD RECURRENCE OF RIGHT V2 TRIGEMINAL NEURALGIA. A NEW UNCOMFORTABLE SENSATION IN RIGHT V2 REGION WAS DEVELOPED AND SENSITIVITY AND ALLODYNIA IN RIGHT V2 REGION. PATIENT ALSO DEVELOPED SHARP SHOOTING PAIN STARTING IN RIGHT TOOTH AND GOING UP TO EYE. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10425729 ↗
• 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. THE PATIENT WAS IMPLANTED WITH A 24MM TI LOW PROFILE NEURO BURR HOLE COVER. POSTOPERATIVELY, THE PATIENT HAD A CEREBRAL SPINE FLUID LEAK. IT WAS RESOLVED WITH A WOUND WASH OUT AND THE MICROVASCULAR DECOMPRESSION PROCEDURE WAS REDONE. THE PATIENT REPORTED FLUID DRIP FROM THE NOSE, AND HEADACHES AFTER THE PROCEDURE. 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: Cerebrospinal Fluid Leakage; Pain

  MAUDE report 10425282 ↗
• InjuryAug 18, 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 PLATES AND BURR HOLE COVER. POSTOPERATIVELY, THE PATIENT WENT TO ER FOR PERIPHERAL SEVENTH NERVE PALSY. THE PATIENT'S HEAD CT SHOWED NO ACUTE FINDINGS. HENCE PATIENT WAS DIAGNOSED WITH BELL'S PALSY UNRELATED TO SURGERY, HAS IMPROVED ON ITS OWN AND WAS RESOLVED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10422496 ↗
• InjuryAug 17, 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 TITANIUM LOW PROFILE NEURO BURR HOLE COVER. THERE WAS A SURGICAL TIME OF 93 MINUTES. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. THE DURATION OF FOLLOW UP WAS OF 2050 DAYS. THE HEALING STATUS/RADIOGRAPHIC OUTCOMES AT FINAL FOLLOW-UP WAS THAT THE PATIENT PAIN RELIEF FROM SURGERY CONTINUES TO THIS DAY AND REPORTS IMPROVEMENT IN SYMPTOMS FROM CSF LEAK INTO MIDDLE EAR. THERE WAS NO POSTOPERATIVE COMPLICATION PRESENTED. THE PATIENT UNDERWENT REOPERATION BECAUSE OF THE RIGHT RETROSIGMOID CRANIOTOMY REPAIR OF CSF LEAK. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVED UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Cerebrospinal Fluid Leakage; No Code Available

  MAUDE report 10414081 ↗
• InjuryAug 14, 2020No Apparent Adverse Event; No Apparent Adverse Event

  UPDATED EVENT DESCRIPTION: THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES.

  Patient problems: No Code Available; Pain

  MAUDE report 10407948 ↗
• InjuryDec 19, 2018Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A DEBRIDEMENT OF SURGICAL SITE WITH REMOVAL OF RETAINED HARDWARE AND BONE AND OPEN REDUCTION INTERNAL FIXATION (ORIF) OF CRANIUM DUE TO INFECTION. ONE (1) TITANIUM LOW PROFILE NEURO STRUT PLATE, THREE (3) TITANIUM LOW PROFILE NEURO BURR HOLE COVER, AND SIXTEEN (16) TITANIUM LOW PROFILE NEURO SCREW SELF-DRILLING WAS REMOVED DUE TO LOCAL INFECTION AT THE SITE. PATIENT INITIALLY INJURED SELF IN A MOTOR VEHICULAR ACCIDENT (MVA) AND WAS EJECTED FROM THE CAR. PATIENT HAD MULTIPLE SURGERIES TO MULTIPLE AREAS INCLUDING HER HEAD AND MULTIPLE DEBRIDEMENTS FROM THE INITIAL SURGERY ON (B)(6) 2018. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT IS STILL IN COMA. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. PLEASE SEE THE LINKED COMPLAINT (B)(4) WHICH CAPTURES THE ADDITIONAL 10 DEVICES. THIS COMPLAINT IS FOR ONE (1) TI LOW PROFILE NEURO STRUT PLATE 6 HOLES. THIS REPORT IS 4 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8182099 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A DEBRIDEMENT OF SURGICAL SITE WITH REMOVAL OF RETAINED HARDWARE AND BONE AND OPEN REDUCTION INTERNAL FIXATION (ORIF) OF CRANIUM DUE TO INFECTION. ONE (1) TITANIUM LOW PROFILE NEURO STRUT PLATE, THREE (3) TITANIUM LOW PROFILE NEURO BURR HOLE COVER, AND SIXTEEN (16) TITANIUM LOW PROFILE NEURO SCREW SELF-DRILLING WAS REMOVED DUE TO LOCAL INFECTION AT THE SITE. PATIENT INITIALLY INJURED SELF IN A MOTOR VEHICULAR ACCIDENT (MVA) AND WAS EJECTED FROM THE CAR. PATIENT HAD MULTIPLE SURGERIES TO MULTIPLE AREAS INCLUDING HER HEAD AND MULTIPLE DEBRIDEMENTS FROM THE INITIAL SURGERY ON (B)(6) 2018. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT IS STILL IN COMA. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. PLEASE SEE THE LINKED COMPLAINT (B)(4) WHICH CAPTURES THE ADDITIONAL 10 DEVICES. THIS COMPLAINT IS FOR ONE (1) TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA. THIS REPORT IS 3 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8182088 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A DEBRIDEMENT OF SURGICAL SITE WITH REMOVAL OF RETAINED HARDWARE AND BONE AND OPEN REDUCTION INTERNAL FIXATION (ORIF) OF CRANIUM DUE TO INFECTION. ONE (1) TITANIUM LOW PROFILE NEURO STRUT PLATE, THREE (3) TITANIUM LOW PROFILE NEURO BURR HOLE COVER, AND SIXTEEN (16) TITANIUM LOW PROFILE NEURO SCREW SELF-DRILLING WAS REMOVED DUE TO LOCAL INFECTION AT THE SITE. PATIENT INITIALLY INJURED SELF IN A MOTOR VEHICULAR ACCIDENT (MVA) AND WAS EJECTED FROM THE CAR. PATIENT HAD MULTIPLE SURGERIES TO MULTIPLE AREAS INCLUDING HER HEAD AND MULTIPLE DEBRIDEMENTS FROM THE INITIAL SURGERY ON (B)(6) 2018. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT IS STILL IN COMA. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. PLEASE SEE THE LINKED COMPLAINT (B)(4) WHICH CAPTURES THE ADDITIONAL 10 DEVICES. THIS COMPLAINT IS FOR ONE (1) TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA. THIS REPORT IS 2 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8182086 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A DEBRIDEMENT OF SURGICAL SITE WITH REMOVAL OF RETAINED HARDWARE AND BONE AND OPEN REDUCTION INTERNAL FIXATION (ORIF) OF CRANIUM DUE TO INFECTION. ONE (1) TITANIUM LOW PROFILE NEURO STRUT PLATE, THREE (3) TITANIUM LOW PROFILE NEURO BURR HOLE COVER, AND SIXTEEN (16) TITANIUM LOW PROFILE NEURO SCREW SELF-DRILLING WAS REMOVED DUE TO LOCAL INFECTION AT THE SITE. PATIENT INITIALLY INJURED SELF IN A MOTOR VEHICULAR ACCIDENT (MVA) AND WAS EJECTED FROM THE CAR. PATIENT HAD MULTIPLE SURGERIES TO MULTIPLE AREAS INCLUDING HER HEAD AND MULTIPLE DEBRIDEMENTS FROM THE INITIAL SURGERY ON (B)(6) 2018. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT IS STILL IN COMA. THIS COMPLAINT INVOLVES TWENTY (20) DEVICES. PLEASE SEE THE LINKED COMPLAINT (B)(4) WHICH CAPTURES THE ADDITIONAL 10 DEVICES. THIS COMPLAINT IS FOR ONE (1) TI LOW PROFILE NEURO BURR HOLE COVER 24MM DIA. THIS REPORT IS 1 OF 10 FOR (B)(4)

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8182085 ↗