CRANIOS Reinforced 615.05.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10887587058641), received between Aug 10, 2020 and Jun 30, 2022 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT HAD CRANIOS FAST SET PUTTY IMPLANTED FOR A CALVARIAL BONE GRAFT HAS A SURGICAL SITE INFECTION AND THEN HAD TO HAVE AN ADDITIONAL SURGERY TO FIX THE INFECTION. THE INFECTION CAME FROM HOSPITAL INSTRUMENTS ACCORDING TO THE SURGEON. PROCEDURE WAS UNKNOWN AND PATIENT CONSEQUENCES WERE REPORTED IN THIS EVENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE CRANIOS REINFORCED FAST SET PUTTY 5CC-S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14876180 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF THE IMPLANT TO WASH OUT INFECTIONS THAT HAVE USED CRANIOS FAST SET PUTTY. ORIGINALLY, THE PATIENT UNDERWENT LEFT RETROSIGMOID CRANIOTOMY ON (B)(6) 2018. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 11324769 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE SURGEON USED TWO (2) CRANIOS FAST SET PUTTIES FOR LEFT RETROSIGMOID CRANIOTOMY. ON (B)(6) 2018 THE PATIENT HAD A CT SCAN OF THE HEAD THAT WAS UNREMARKABLE. THE PATIENT PRESENTED ON AN UNKNOWN DATE WITH POST-OP INFECTION, INFLAMMATION, HEADACHE AND PAIN. ON (B)(6) 2018 THE PATIENT UNDERWENT INCISION WITH DRAINAGE AND IMPLANTS WERE REMOVED. THE WASHED-OUT MATERIAL HAS BEEN REPORTED TO LOOK LIKE SPACKLE, AND THE SURGICAL TEAM HAS NOT RETAINED MATERIAL TO SHIP BACK FOR INVESTIGATION. THE SURGEON NOTED THAT IT WAS NOT KNOWN IF THE CRANIOS WAS SOLELY RESPONSIBLE FOR THE INFECTION. APPARENTLY SURGEON HAD FIVE (5) SUCH CASES WHERE HE HAD TO WASH OUT THE PATIENTS. THIS COMPLAINT CAPTURES 1ST CASE, OTHER 4 CASES ARE CAPTURED UNDER RELATED (B)(4). THIS REPORT IS FOR ONE (1) CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Inflammation; Pain; Wound Infection

  MAUDE report 11323320 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THE PROCEDURE WAS A BICORONAL CRANIOTOMY.

  Patient problems: Inflammation; No Code Available; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 10844189 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THE PROCEDURE WAS A LEFT RETROSIGMOID CRANIOTOMY.

  Patient problems: Inflammation; No Code Available; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 10844184 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THE PROCEDURE WAS A RIGHT FRONTAL CRANIOTOMY.

  Patient problems: Inflammation; No Code Available; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 10844162 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THE PROCEDURE WAS A RIGHT RETROSIGMOID CRANIOTOMY.

  Patient problems: Inflammation; No Code Available; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 10844055 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2017, THE SURGEON USED TWO (2) CRANIOS FAST SET PUTTIES FOR LEFT RETROSIGMOID CRANIOTOMY. ON (B)(6) 2018, THE PATIENT HAD A CT SCAN OF THE HEAD THAT WAS UNREMARKABLE. THE PATIENT PRESENTED ON AN UNKNOWN DATE WITH POST-OP INFECTION, INFLAMMATION, HEADACHE AND PAIN. ON (B)(6) 2018, THE PATIENT UNDERWENT INCISION WITH DRAINAGE AND IMPLANTS WERE REMOVED. THE WASHED-OUT MATERIAL HAS BEEN REPORTED TO LOOK LIKE SPACKLE, AND THE SURGICAL TEAM HAS NOT RETAINED MATERIAL TO SHIP BACK FOR INVESTIGATION. THE SURGEON NOTED THAT IT WAS NOT KNOWN IF THE CRANIOS WAS SOLELY RESPONSIBLE FOR THE INFECTION. APPARENTLY SURGEON HAD FIVE (5) SUCH CASES WHERE HE HAD TO WASH OUT THE PATIENTS. THIS COMPLAINT CAPTURES 1ST CASE, OTHER 4 CASES ARE CAPTURED UNDER RELATED COMPLAINTS (B)(4). THIS REPORT IS FOR ONE (1) CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT: (B)(4).

  Patient problems: Inflammation; No Code Available; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 10844011 ↗
• 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 PUTTY CEMENT NORIAN 5CC. POSTOPERATIVELY, WHEN THE SURGEON WENT TO CUT IT, THE PATIENT'S HEARING DECREASED TO 1M SECOND DELAY ON THE BAERS. THEREFORE, HE CUT ONLY PART OF THE NERVUS INTERMEDIUS. THE SURGEON DECIDED NOT TO PURSUE IT ANY FURTHER AS THE PATIENT HAS NO HEARING ON THE CONTRALATERAL EAR AND THE POSTOPERATIVE COMPLICATION WAS RESOLVED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Hearing Impairment; No Code Available

  MAUDE report 10426415 ↗
• 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 AN ACOUSTIC NEUROMA RESECTION RETROSIGMOID PROCEDURE. THE PATIENT WAS IMPLANTED WITH TITANIUM MATRIXNEURO ADAPTATION PLATE AND CRANIOS REINFORCED FAST SET PUTTY. THERE WAS A SURGICAL TIME OF 568 MINUTES. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. POSTOPERATIVELY, ON AN UNKNOWN DATE, PATIENT WAS ADMITTED TO HOSPITAL FOR WOUND DRAINAGE, STOPPED WITH GLUE. IT WAS UNCLEAR WHETHER POSTOPERATIVE COMPLICATION(S) WAS (WERE) DUE TO DEVICE. THE INFECTED BONE PLATE TREATED WITH SURGERY TO REMOVE ALL HARDWARE. THE HEALING STATUS/RADIOGRAPHIC OUTCOMES AT FINAL FOLLOW-UP WAS THE LARGE SYMPTOMATIC LEFT ACOUSTIC NEUROMA DOING GREAT AFTER NEAR TOTAL RESECTION OF SCHWANNOMA. INFECTION HAS BEEN TREATED, AND HIS WOUND LOOKS GOOD. HE HAS NO BONE FLAP BECAUSE IT WAS REMOVED FOR INFECTION. OTHER OUTCOME ASSESSMENTS OR PATIENT REPORTED OUTCOMES WAS THE LEFT EYE TEARING AT TIMES WHILE EATING. ONGOING NECK SPASMS AND SORENESS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 10425912 ↗
• 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 PLATES AND PUTTY CEMENT. POSTOPERATIVELY, THE PATIENT HAD A RIGHT WOUND DEHISCENCE AND WOUND WASHOUT AND HARDWARE REMOVAL WERE DONE AND INFECTION WAS RESOLVED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Wound Dehiscence

  MAUDE report 10420419 ↗
• 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 PLATES AND PUTTY CEMENT. POSTOPERATIVELY, THE PATIENT HAD A RIGHT WOUND DEHISCENCE AND WOUND WASHOUT AND HARDWARE REMOVAL WERE DONE AND INFECTION WAS RESOLVED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Wound Dehiscence

  MAUDE report 10420321 ↗
• 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, QUANTITY# 1). TI LOW PROFILE NEURO ADAPTION PLATE 20 HOLES (PART#: 421.520, LOT#: UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

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

  MAUDE report 10407872 ↗
• 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# DSC6246, QUANTITY# 1), TI LOW PROFILE NEURO ADAPTION PLATE 20 HOLES (PART# 421.520, LOT# UNKNOWN, QUANTITY# 1) THIS REPORT IS FOR 1 CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

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

  MAUDE report 10407857 ↗
• InjuryAug 13, 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/CRANIOTOMY AND SURGERY FOR WOUND WASHOUT AND REMOVAL OF HARDWARE. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE OUTCOMES WERE UNKNOWN. THE PATIENT WAS DOING WELL AFTER CRANIOTOMY/RESECTION AND THEN WOUND WASHOUT AND REMOVAL OF HARDWARE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10401654 ↗
• 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) CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10398892 ↗
• 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) CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 10387783 ↗