CRANIOS Reinforced 615.10.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10887587058658), received between Jan 14, 2020 and Jul 23, 2021 — classified as 10 injuries, 1 malfunction.

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, 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 PLATE AND PUTTY CEMENT. THE PATIENT HAD MEDIUM SIZE S/P RESECTION OF CP ANGLE COMPONENT COMPLICATED BY INABILITY TO OPEN IAC BECAUSE OF SEVERE CEREBELLAR SWELLING, REQUIRING DECOMPRESSIVE CEREBELLAR CRANIECTOMY TWO DAYS LATER AND WAS RESOLVED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A CRANIO'S REINFORCED FAST SET PUTTY 10CC-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Swelling

  MAUDE report 10421202 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ACOUSTIC NEUROMA RESECTION RETROSIGMOID PROCEDURE. THE PATIENT WAS IMPLANTED WITH THE TITANIUM MATRIXNEURO ADAPTATION PLATE AND PUTTY CEMENT. THERE WAS A SURGICAL TIME OF 559 MINUTES. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THE PATIENT IS DOING GREAT AFTER GROSS TOTAL RESECTION OF A MASSIVE VESTIBULAR SCHWANNOMA AND A SCAR IN THE IAC. THE PATIENT REPORTS LOW BACK PAIN AND ISSUES WITH SLEEPING RECENTLY. PATIENT HAS NO HEARING ON THE RIGHT SIDE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Hearing Impairment; Pain

  MAUDE report 10420109 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: 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 MATRIXNEURO CONTOURABLE MESH PLATES AND CRANIOS REINFORCED FAST SET PUTTY CEMENT. THERE WAS A SURGICAL TIME OF 118 MINUTES. THERE WAS NO INTRAOPERATIVE COMPLICATION. THE HEALING STATUS AND RADIOGRAPHIC OUTCOME AT THE FINAL FOLLOW-UP WAS THAT THE PATIENT REPORTS 100% RELIEF, VERY MUCH IMPROVED, AND THE PATIENT IS OFF ALL DRUGS. THERE WAS NO POSTOPERATIVE COMPLICATION PRESENTED. THE PATIENT UNDERGO RIGHT-SIDED CRANIOPLASTY AND REVISION BECAUSE OF PERSISTENT OCCIPITAL HEADACHES, LEFT MICROVASCULAR DECOMPRESSION. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES.

  Patient problems: Headache

  MAUDE report 10391007 ↗
• InjuryJan 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 A REMOVAL OF CRANIOS REINFORCED FAST SET PUTTY, ONE (1) TITANIUM MATRIXNEURO RECONSTRUCTION MESH, ONE (1) 3 MM TITANIUM MATRIX MIDFACE SCREW, ONE (1) 10 MM TITANIUM MATRIX MIDFACE SCREW, AND ONE (1) 4 MM TITANIUM MATRIX MIDFACE SCREW DUE TO C DIFFICILE INFECTION POSTOPERATIVELY. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2015. THE PATIENT WAS ON A CEPHALEXIN ANTIBIOTIC THERAPY DUE TO COMPLICATION KNOWN ON (B)(6) 2015. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) CRANIOS REINFORCED FAST SET PUTTY 10 CC-STERILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9587413 ↗
• InjuryJan 14, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL OF BONE CEMENT DUE TO CEMENT FRAGMENTATION AND INFECTION THAT WAS KNOWN ON (B)(6) 2017. FINDINGS AT LAST FOLLOW-UP TEMPORAL RETRUSION RIGHT, LEFT POSTERIOR SKULL BONY CONTOUR IRREGULARITIES. THE PATIENT PARTICIPATES IN MARTIAL ARTS AND NOTES REPEATED TRAUMA TO THE HEAD AND, OVER THE PAST SEVERAL MONTHS, HAD NOTED SOME BOGGY INFLAMMATION IN THE RIGHT FOREHEAD REGION WITHOUT FRANK INFECTION. MORE RECENTLY, IT DEVELOPED A SMALL ABSCESS ON THE UPPER LID ON THE RIGHT, SUGGESTING SOME SORT OF INFECTION OF THE ALLOPLAST, WHICH HAD PRESUMED TO BE TRAUMATICALLY FRAGMENTED, HAD CHRONIC INFLAMMATION AND FRAGMENTATION OF THE PHOSPHATE CEMENT BOTH ON THE RIGHT AND LEFT TEMPORAL REGIONS. IT APPEARS THAT THE PATIENT HAD THIS WITH AN INFECTION THROUGH THE RIGHT UPPER LID. THE ORIGINAL IMPLANT DATE WAS ON (B)(6) 2016. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN. THIS REPORT IS FOR ONE (1) CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 9587274 ↗
• InjuryJan 14, 2020Break; Break

  MODIFIED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL OF BONE CEMENT DUE TO CEMENT FRAGMENTATION AND INFECTION THAT WAS KNOWN ON (B)(6) 2017. THE PATIENT HAD CEPHALEXIN ANTIBIOTIC THERAPY FOR A PERIOD OF TIME. FINDINGS AT LAST FOLLOW-UP TEMPORAL RETRUSION RIGHT, LEFT POSTERIOR SKULL BONY CONTOUR IRREGULARITIES. REOPERATIVE FINDINGS THE PATIENT PARTICIPATES IN MARTIAL ARTS AND NOTES REPEATED TRAUMA TO THE HEAD AND, OVER THE PAST SEVERAL MONTHS, HAD NOTED SOME BOGGY INFLAMMATION IN THE RIGHT FOREHEAD REGION WITHOUT FRANK INFECTION. MORE RECENTLY, IT DEVELOPED A SMALL ABSCESS ON THE UPPER LID ON THE RIGHT, SUGGESTING SOME SORT OF INFECTION OF THE ELASTOPLAST, WHICH HAD PRESUMED TO BE TRAUMATICALLY FRAGMENTED, HAD CHRONIC INFLAMMATION AND FRAGMENTATION OF THE PHOSPHATE CEMENT BOTH ON THE RIGHT AND LEFT TEMPORAL REGIONS. IT APPEARS THAT THE PATIENT HAD THIS WITH AN INFECTION THROUGH THE RIGHT UPPER LID. THE ORIGINAL IMPLANT DATE WAS ON (B)(6) 2016. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN.

  Patient problems: Inflammation; No Code Available; Unspecified Infection

  MAUDE report 9587247 ↗
• InjuryJan 14, 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) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO CHRONIC INFECTION. ORIGINALLY, THE PATIENT HAD AN IMPLANTATION USING A TITANIUM MESH AND SCREWS DUE TO CRANIAL VAULT RESHAPING IN INFANCY IN (B)(6) 2016. HOWEVER, COMPLICATION WAS OBSERVED DUE TO INFECTION THAT WAS KNOWN IN (B)(6) 2016 AND THAT PATIENT WAS ON ANTIBIOTIC THERAPY OF CEPHALEXIN. THUS, A RE-OPERATION WAS DONE IN (B)(6) 2016. UNFORTUNATELY, A RE-OPERATIVE FINDING SHOWN THAT THE CRANIOPLASTY MATERIAL IN SOME AREAS LOOKED QUITE SATISFACTORY BUT IN OTHER AREAS WAS OBVIOUSLY INFECTED. IT WAS ALSO MENTIONED THAT THIS WOULD NEED TO BE REMOVED, AND THE SURGEON AWARE THAT THERE WAS A SUBJACENT FRONTAL BONE TITANIUM MESH CRANIOPLASTY ON THE LEFT THAT WOULD NEED TO BE REMOVED AND REPLACED. SO, WOUND CULTURE WAS DONE WITH NORMAL SKIN FLORA, NO FUNGUS WAS NOTED AND WOUND CULTURE IN OFFICE GREW PSEUDOMONAS AND WAS ON BACTRIM AND CIPRO PRE-OP. THUS, ANOTHER SURGERY WAS DONE ON (B)(6) 2019 WHEREIN BONE AND SOFT TISSUES WERE DEBRIDED, AND BONE AND HARDWARE WERE REMOVED IN THE LEFT FRONTAL BONE. THE PATIENT HAS A SHEET OF TITANIUM MESH OVER THE CRANIAL DEFECT IN THE LEFT FRONT

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection

  MAUDE report 9587054 ↗