CRANIOS ReinforcedRecalls & reported problems across all models

We found 4 models of CRANIOS Reinforced by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Jan 14, 2020 and Jun 30, 2022 — classified as 31 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CRANIOS Reinforced problems

CRANIOS Reinforced models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CRANIOS Reinforced 615.05.01S

  METHYL METHACRYLATE FOR CRANIOPLASTY
  17 reports
• CRANIOS Reinforced 615.10.01S

  METHYL METHACRYLATE FOR CRANIOPLASTY
  11 reports
• CRANIOS Reinforced 615.03.01S

  METHYL METHACRYLATE FOR CRANIOPLASTY
  4 reports
• CRANIOS Reinforced 616.05.01S

  METHYL METHACRYLATE FOR CRANIOPLASTY
  1 report

Recent CRANIOS Reinforced adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMar 19, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE THE CIRCULATING NURSE WAS TRYING TO MIX A 5CC CRANIOS REINFORCED ROTARY MIX, AND WHEN THE NURSE ATTACHED THE SOLUTION SYRINGE TO THE ONE WAY VALVE AND STARTED TO INJECT THE SOLUTION WOULD NOT GO INTO THE MIXING POUCH AND BEGAN LEAKING OUT THROUGH THE LUER LOCK SYRINGE AND THE ONE WAY VALVE. NO DELAY IN SURGERY. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE CRANIOS REINFORCED ROTARY MIX 5CC-SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827560 ↗
• MalfunctionJul 23, 2021Migration; Migration

  THE PATIENT HAD CRACKING OF THE CRANIOS UNDER THE SKIN WHICH CAUSED AN INFECTION AND THE PATIENT HAD TO HAVE MULTIPLE WASHOUTS AND DEBRIDEMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218832 ↗
• InjuryJul 23, 2021Break; Break

  THE PATIENT HAD CRACKING OF THE CRANIOS UNDER THE SKIN WHICH CAUSED AN INFECTION AND THE PATIENT HAD TO HAVE MULTIPLE WASHOUTS AND DEBRIDEMENTS.

  Patient problems: Pocket Erosion

  MAUDE report 12218718 ↗
• InjuryJul 23, 2021Migration; Migration

  IT WAS REPORTED THAT SEVERAL YEARS POSTOPERATIVELY, PATIENT EXPERIENCED CRACKING OF THE CRANIOS REINFORCED FAST SET PUTTY WHICH CAUSED AN INFECTION. THE PATIENT HAD TO HAVE MULTIPLE WASHOUTS AND DEBRIDEMENTS. THIS REPORT IS FOR A CRANIOS REINFORCED FAST SET PUTTY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 12217918 ↗
• 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 ↗
• InjuryFeb 2, 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 TWO (2) CRANIOS FAST SET PUTTY 10CC TO WASH OUT INFECTIONS SINCE THE INCISION HAD DRAINAGE. ORIGINALLY, THE PATIENT UNDERWENT A BICORONAL CRANIOTOMY ON (B)(6) 2019. A HEAD CT SCAN WAS TAKEN ON (B)(6) 2020. THE SURGEON TOOK THE PATIENT BACK TO THE OPERATING ROOM AND WASHED/DEBRIDED OUT THE INFECTION. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. APPARENTLY SURGEON HAD FIVE (5) SUCH CASES WHERE HE HAD TO WASH OUT THE PATIENTS. THIS COMPLAINT CAPTURES 5TH CASE, OTHER 4 CASES ARE CAPTURED UNDER RELATED (B)(4). THIS REPORT IS FOR ONE (1) CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 11269141 ↗
• 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 ↗

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