NA 421.520Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587050539), received between Aug 10, 2020 and Aug 14, 2020 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 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 AN ACOUSTIC NEUROMA RESECTION RETROSIGMOID PROCEDURE. PATIENT WAS IMPLANTED WITH UNKNOWN BONE PLATES AND PUTTY CEMENT. THE PATIENT WENT TO ER FOR HEADACHE, NAUSEA, VOMITING AND WAS RESOLVED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A TITANIUM (TI) LOW PROFILE NEURO ADAPTION PLATE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Headache; Nausea; No Code Available; Vomiting

  MAUDE report 10408716 ↗
• InjuryAug 14, 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 AN ACOUSTIC NEUROMA RESECTION RETROSIGMOID PROCEDURE DUE TO ACOUSTIC NEUROMA. THE PATIENT WAS IMPLANTED WITH UNKNOWN BONE PLATES AND CRANIOS REINFORCED FAST SST PUTTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO POST-OPERATIVE COMPLICATIONS. OTHER OUTCOME ASSESSMENTS OR PATIENT-REPORTED OUTCOMES WERE DECREASED PERIPHERAL VISION ON THE RIGHT, HEADACHES, DECREASED APPETITE, FIRST BITE SYNDROME, GAIT UNSTEADY, DYSPHONIA, CONTRALATERAL VOCAL CORD PARALYSIS, DIPLOPIA ON LATERAL GAZE TO THE RIGHT (RIGHT VI PARIETAL) IN RIGHT LATERAL GAZE, ENDGAZE NYSTAGMUS, AND AMPLITUDE SKEW DEVIATION. HE IS EXPERIENCING OSCILLOPSIA IN THE RIGHT LATERAL GAZE. ANY FURTHER PROCEDURE OR PATIENT OUTCOMES WERE NOT REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE (PART # 615.05.01S, LOT # DSC3595/ DSC6246, QUANTITY # 2). THIS REPORT IS FOR ONE (1) TI LOW PROFILE NEURO ADAPTION PLATE 20 HOLES. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Headache; Neurological Deficit/Dysfunction; Pain; Visual Impairment

  MAUDE report 10407860 ↗
• InjuryAug 12, 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 AN ACOUSTIC NEUROMA RESECTION RETROSIGMOID PROCEDURE. THE PATIENT WAS IMPLANTED WITH AN UNKNOWN BONE PLATES AND PUTTY CEMENT. POSTOPERATIVELY, THE PATIENT WAS ADMITTED TO HOSPITAL FOR ILLICIT POLYPHARMACY THAT WAS RESOLVED. REPORTS OCCASIONAL EAR PAIN. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI LOW PROFILE NEURO ADAPTION PLATE 20 HOLES. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10398918 ↗
• InjuryAug 10, 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 AN ACOUSTIC NEUROMA RESECTION RETROSIGMOID PROCEDURE. THE PATIENT WAS IMPLANTED WITH AN UNKNOWN BONE PLATE AND PUTTY CEMENT. THE PATIENT REPORTED THAT HER BALANCE GOT WORSE AND HAD FALLEN SEVERAL TIMES IN THE LAST SIX (6) WEEKS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI LOW PROFILE NEURO ADAPTION PLATE 20 HOLES. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 10387926 ↗