CRANIOS Reinforced 615.03.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587058634), received between Aug 7, 2020 and Aug 18, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 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 AN ACOUSTIC NEUROMA RESECTION RETROSIGMOID PROCEDURE. PATIENT WAS IMPLANTED WITH AN UNKNOWN BONE PLATES AND PUTTY CEMENT. POSTOPERATIVELY, THE PATIENT'S SURGERY WAS COMPLICATED BY SWELLING OF THE NECK WHICH REQUIRED THE PATIENT TO BE KEPT INTUBATED FOR AN EXTRA TWO DAYS FOR AIRWAY PROTECTION. THE PATIENT'S SHOULDER WAS MILDLY WEAK AFTER THE SURGERY AND WAS ATTRIBUTED TO BRACHIAL PLEXUS STRETCH INJURY. THE PATIENT IS MAKING GOOD PROGRESS AND THE POST OPERATIVE COMPLICATIONS WERE RESOLVED. PATIENT'S OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Swelling; Weakness

  MAUDE report 10420587 ↗
• 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 CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

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

  MAUDE report 10408649 ↗
• InjuryAug 11, 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. IMMEDIATELY AFTER THE SURGERY, THE PATIENT EXPERIENCED SEVERE FACIAL PARALYSIS. THE PATIENT HAD RIGHT MASSETER NERVE TO FACIAL NERVE TRANSFER, AND TEMPORALIS TENDON TRANSFER. THE COMPLICATION WAS RESOLVED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Facial Nerve Paralysis

  MAUDE report 10391577 ↗
• InjuryAug 7, 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 AN UNKNOWN BONE PLATE AND PUTTY CEMENT. POSTOPERATIVELY, THE PATIENT DEVELOPED CSF RHINORRHEA AND WAS HOSPITALIZED FOR MENINGITIS. THE HEAD CT SHOWED PNEUMOCEPHALUS AND CSF RHINORRHEA. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND POST-OPERATIVE COMPLICATIONS WERE RESOLVED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), TI MATRIXMIDFACE OBLIQUE L-PL 2X3 HOLES-LEFT/0.8MM THICK (PART# 04.503.383, LOT# UNKNOWN, QUANTITY# 1), TI MATRIXMIDFACE H-PLATE 11 HOLES/0.8MM THICK (PART# 04.503.382, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 10380144 ↗