NA SD800.427Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10887587065007), received between Dec 8, 2017 and Sep 4, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT ON AUGUST 6, 2024, SALES CONSULTANT RECEIVED NOTIFICATION FROM THE FIELD THAT THIS IMPLANT DID NOT FIT PROPERLY SO IT WAS NOT IMPLANTED. DEFECT WAS NOT ABLE TO BE COVERED USING THE PATIENT SPECIFIC IMPLANT BUT WAS INSTEAD COVERED USING TITANIUM MESH. SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE DELAY. THIS REPORT IS FOR ONE PSI SD800.427 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20137144 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE INITIAL SURGERY WENT WELL AND THE PATIENT WAS SENT HOME TO RECOVER ON (B)(6) 2021. THE PATIENT WAS EXPERIENCING SWELLING ON THE SURGICAL SITE AFTER SURGERY AND THE PATIENT WAS SENT TO RECOVER AGAIN ON (B)(6) 2022. THE TREATMENT INCLUDED ANTIBIOTICS, AND THE SWELLING IS GOING DOWN CURRENTLY. THIS REPORT IS FOR ONE (1) PSI SD800.427 PEEK IMPLANT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Swelling/ Edema

  MAUDE report 13515525 ↗
• InjuryOct 6, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A CRANIOPLASTY. DURING THE PROCEDURE, THE SURGEON WAS NOT SATISFIED WITH THE FIT OF THE PEEK IMPLANT RECEIVED. THE PEEK IMPLANT HAD TO BE MODIFIED INTRAOPERATIVELY. THE DOCTOR BURRED BOTH THE BONEY PROMINENCE AND THE PEEK IMPLANT. NOT MUCH BURRING WAS NEEDED TO GET A GOOD FIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT'S STATUS WAS REPORTED AS GREAT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) PSI SD800.427 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10638220 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH POLYETHERETHERKETONE (PEEK) PATIENT-SPECIFIC IMPLANTS (PSI) AS A BIFRONTAL CRANIOPLASTY ON AN UNKNOWN DATE. AFTER APPROXIMATELY ONE MONTH, THE IMPLANTS HAD TO BE REMOVED DUE TO INFECTION. IT IS UNKNOWN IF IMPLANTS WERE SUCCESSFULLY REMOVED. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. THIS REPORT IS FOR A PSI SD800.427 PEEK IMPLANT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7537185 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT BECAME INFECTED BY E. COLI AT THE SURGICAL SITE. THE ORIGINAL IMPLANT OCCURRED (B)(6) 2018. THE SURGEON INDICATED THE E. COLI WAS DUE TO UNHEALTHY LIVING CONDITIONS OF THE PATIENT. THE EXPLANTATION OF THE TWO PSI IMPLANTS AND TI MATRIXNEURO SCREWS HAS NOT OCCURRED AT THIS TIME. A CRANIOPLASTY IS SCHEDULED IN THREE TO FOUR (3-4) WEEKS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7494812 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT BECAME INFECTED BY E. COLI AT THE SURGICAL SITE. THE ORIGINAL IMPLANT OCCURRED (B)(6) 2018. THE SURGEON INDICATED THE E. COLI WAS DUE TO UNHEALTHY LIVING CONDITIONS OF THE PATIENT. THE EXPLANTATION OF THE TWO PSI IMPLANTS AND TI MATRIXNEURO SCREWS HAS NOT OCCURRED AT THIS TIME. A CRANIOPLASTY IS SCHEDULED IN THREE TO FOUR (3-4) WEEKS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7494785 ↗
• InjuryFeb 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT SURGERY FOR REPAIR OF CRANIAL DEFECT ON (B)(6) 2017 WAS ADMITTED TO THE EMERGENCY ROOM ON (B)(6) 2018, WITH AN INFECTION AND WAS SUBSEQUENTLY REVISED THAT DAY. THE PEEK PSI IMPLANT AND AN UNKNOWN NUMBER OF UNKNOWN PLATES AND SCREWS WERE REMOVED TO ALLOW THE ACTIVE INFECTION TO HEAL; NO ADDITIONAL IMPLANTS WERE PLACED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO INTRAOPERATIVE EVENTS OR SURGICAL DELAYS. THE PATIENT WILL BE REVISED ONCE SHE HAS HEALED. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) PEEK IMPLANT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7242230 ↗
• InjuryDec 8, 2017Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT A CRANIOPLASTY SURGERY. DURING THE SURGERY, THE PATIENT SPECIFIC CUSTOM-MADE PEEK SPACER DID NOT FIT TO THE PATIENT'S ANATOMY AS NEEDED. SURGEON PROCEEDED TO COMPLETE THE SURGERY AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE WAS NO REPORTED SURGICAL DELAY. THIS REPORT IS FOR ONE (1) PSI SD800.427 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body Reaction; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7100265 ↗