NA SD800.440Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10887587065113), received between Feb 1, 2017 and Oct 25, 2024 — classified as 18 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE DOCTOR THAT THE PATIENT DEVELOPED ANOTHER INFECTION AFTER CRANIOPLASTY WAS DONE LAST MONDAY. THE DOCTOR DOES NOT BELIEVE IT IS THE IMPLANTS, HE BELIEVES IT HAS TO DO WITH THE PATIENT'S OWN HEALTH. THE NOTIFICATION HAS BEEN RECEIVED FROM THE FIELD THAT AN IMPLANT WAS REMOVED. THE DOCTOR STATES IT WAS NOT AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20531603 ↗
• MalfunctionJun 17, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT AN URGENT REQUEST FOR A PEEK IMPLANT WAS RECEIVED ON (B)(6) 2024 AND IMMEDIATELY UPLOADED THE CT DATA. ON (B)(6) 2024 THE MOST TENURED COORDINATOR IN THIS GROUP EMAILED THE PROPOSED IMPLANT DESIGN TO A RANDOM PERSON WITH A SIMILAR LAST NAME AS THE REQUESTING SURGEON HOWEVER THE MISTAKE WAS ONLY REALIZED AT 8PM THAT NIGHT. BEFORE THE ISSUE WAS NOTICED WE BADGERED THE SURGEON FOR A RESPONSE IN ORDER TO MEET THE SURGICAL DATE OF MONDAY (B)(6) 2024. THIS GROUP WILL NOT MOVE AN IMPLANT INTO PRODUCTION UNTIL A EMAILED RESPONSE FROM THE SURGEON IS RECEIVED. DURING THIS HASSLE THE SURGICAL DATE MOVED TO TUESDAY (B)(6) 2024. ON THE DAY OF SURGERY, IT WAS NOTICED THAT THE IMPLANT LOOKED DIFFERENT THAN WHAT WAS REQUESTED BY THE SURGEON. AFTER REVIEWING EMAILS, IT WAS THEN CONFIRMED THAT THE ENGINEER DESIGNED AND MANUFACTURED AN IMPLANT THAT WAS THE EXACT OPPOSITE OF WHAT SURGEON HAS REQUESTED. THIS REPORT IS FOR ONE (1) PSI SD800.440 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19550116 ↗
• MalfunctionJun 13, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THIS IMPLANT HAD A SLIGHT FITMENT ISSUE DURING SURGERY. THE IMPLANT SAT A BIT HIGH ALONG THE POSTERIOR EDGE. THE IMPLANT WAS STILL USED AND ADDED NO ADDITIONAL TIME TO THE CASE. THIS WAS MADE AWARE DURING A ROUTINE CHECK-IN WITH THE SURGEON. THIS REPORT INVOLVES ONE (1) PSI SD800.440 PEEK IMPLANT THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19533382 ↗
• InjuryApr 23, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING CRANIOPLASTY. THE SURGEON FOUND THE CUSTOMIZED PEEK IMPLANT WAS UNABLE TO FIT PATIENT'S SKULL DEFECT. THE SURGEON HAD TO MODIFY THE SKULL-BONE, THIS WAS A SIZE ISSUE AND CLAIMED THAT MORE THAN 5MM SKULL HAD BEEN MODIFIED. AFTER MODIFIED AND IMPLANTATION, THERE WAS STILL SOME UNEVEN. THE PROCEDURE TIME EXPANDED ABOUT 45 MINS. PATIENT STATUS IS UNKNOWN AND HAS BEEN DISCHARGED. THE SURGERY WAS COMPLETED SUCCESSFULLY, THIS REPORT IS FOR ONE (1) PSI SD800.440 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19168593 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON JANUARY 8 2024 DATE THAT THEY RECEIVED NOTIFICATION FROM THE FIELD THAT THIS IMPLANT HAD TO BE REMOVED DUE TO INFECTION AND WILL UNDERGO A SECOND PROCEDURE TO REPLACE THE BONE FLAP. THIS OCCURRED POST-OP. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) PSI SD800.440 PEEK IMPLANT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18586783 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DR INFORMED THAT A CUSTOM PEEK IMPLANT WAS EXPLANTED AS A RESULT OF AN INFECTION. THEY UNFORTUNATELY HAD TO EXPLANT HER PRIOR IMPLANT DUE TO INFECTION. THE PATIENT HAD ENQUIRY SO REQUEST ANOTHER IMPLANT BE MADE FROM HER PRIOR APPROVED DESIGN FOR ANTICIPATED CRANIOPLASTY IN 1 MONTH WITH DR. THIS REPORT IS FOR ONE (1) PSI SD800.440 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18564109 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN KOREA, SOUTH AS FOLLOWS: IT WAS REPORTED THAT THEY REMOVED PSI DUE TO AN INFECTION IN THE PATIENT'S OPERATED AREA. (THIS PATIENT HAD A PREVIOUS HISTORY OF INFECTION.) DEVICE EXPLANTED DUE TO INFECTION. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) PSI SD800.440 PEEK IMPLANT. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18031633 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE IMPLANT WAS REMOVED DUE TO INFECTION. ADDITIONAL INFORMATION WAS LATER RECEIVED STATING THAT THERE WAS A PREVIOUS INFECTION AND THE SURGEON HAD PUT THE IMPLANT IN TOO SOON. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE PSI SD800.440 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 16102285 ↗
• MalfunctionSep 23, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15474975 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, INFORMATION WAS RECEIVED FROM THE FIELD THAT AN IMPLANT HAD TO BE REMOVED DUE TO INFECTION. THIS REPORT IS FOR ONE (1) PSI SD800.440 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15352550 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THAT AN IMPLANT HAD TO BE REMOVED DUE TO INFECTION (NOT DUE TO THE IMPLANT). THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PSI SD800.440 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15167999 ↗
• MalfunctionDec 22, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THERE WERE ISSUES WITH THE FIT OF THE PSI IMPLANT. THE IMPLANT HAD TO BE MODIFIED INTRAOPERATIVELY. SURGERY WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A PSI SD800.440 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13062831 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  ADDITIONAL EVENT DESCRIPTION THIS (B)(4) WILL CAPTURE THE FOLLOWING DEVICES THAT WERE EXPLANTED DUE TO INFECTION: PSI SD800.440 PEEK IMPLANT QTY: (B)(4) , UNK - PLATES: CMF QTY: (B)(4), UNK - SCREWS: CMF QTY: (B)(4). WHILE, (B)(4) WILL CAPTURE THE OTHER 9 SCREWS THAT WERE EXPLANTED DUE TO INFECTION. A. THE FOLLOWING IP'S WERE CREATED TO CAPTURE THE OTHER 3 PLATES EXPLANTED TOGETHER WITH THE PSI PEEK IMPLANT DUE TO INFECTION: IP-(B)(4): UNK - PLATES: CMF, IP-(B)(4): UNK - PLATES: CMF, IP-(B)(4): UNK - PLATES: CMF. THE FOLLOWING IP'S WERE CREATED TO CAPTURE THE OTHER 4 SCREWS EXPLANTED TOGETHER WITH THE PSI PEEK IMPLANT DUE TO INFECTION: IP-(B)(4) : UNK - SCREWS: CMF, IP-(B)(4) : UNK - SCREWS: CMF, IP-(B)(4) : UNK - SCREWS: CMF , IP-(B)(4) : UNK - SCREWS: CMF. NOTE: THE OTHER 9 SCREWS WILL BE CAPTURED UNDER (B)(4) DUE TO SYSTEM LIMITATION IN CAPTURING THE NUMBER OF IP'S IN PC. THIS COMPLAINT INVOLVES NINETEEN (19) DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 11339431 ↗
• InjuryNov 10, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE PATIENT-SPECIFIC IMPLANT (PSI) PEEK IMPLANT DID NOT FIT AND HAD TO BE MODIFIED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLICATED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) PSI SD800.440 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10818762 ↗
• InjuryJun 17, 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 PSI PEEK IMPLANT HAD TO BE REMOVED DUE TO LEAKAGE. THERE WAS NO REPORTED ISSUE WITH THE DEVICE. THE PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES: SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A PSI PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Cerebrospinal Fluid Leakage; No Code Available

  MAUDE report 10164063 ↗
• InjuryFeb 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, A PATIENT SPECIFIC IMPLANT (PSI) PEEK IMPLANT HAD TO BE REMOVED DUE TO INFECTION. THE PATIENT'S STATUS IS UNKNOWN. THIS REPORT IS FOR A PSI PEEK IMPLANT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9688167 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019: UPDATE: IT WAS REPORTED THAT THERE WASN'T ANY PLANNING AND THE PEEK PSI IS A SYNTHES IMPLANT. THEREFORE MATERIALISE COULD NOT HAVE HAD ANY IMPACT ON THIS INFECTION. THE ORIGINAL MATERIALISE NUMBER WAS MU18-SUN-ZET. THE FINAL IMPLANT WAS GIVEN TO KLS DUE TO CUSTOM TITANIUM IMPLANT THAT WAS NOT AVAILABLE. IN ADDITION, IN ADDITION, THE PATIENT HAD ALREADY HAD THE IMPLANT REMOVED IN A HOSPITAL (HOSPITAL STAFF DIDN¿T KNOW THE NAME OF THE FACILITY) IN ALASKA AND ARE NOT ABLE TO OBTAIN AND SEND THE IMPLANT BACK FOR INSPECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9199218 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PEEK IMPLANT HAD TO BE REMOVED DUE TO AN INFECTION. REMOVAL PROCEDURE HAS BEEN COMPLETED. HOWEVER, NEW DEVICE HAS NOT BEEN IMPLANTED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) PSI SD800.440 PEEK IMPLANT. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8983085 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE POLYETHERETHERKETONE (PEEK) IMPLANT HAD TO BE REMOVED DUE TO INFECTION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8769721 ↗
• InjuryJul 3, 2019Defective Device; Defective Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A CRANIOPLASTY WITH THE PLACEMENT OF A PERSONALIZED PATIENT-SPECIFIC IMPLANT (PSI) PEEK IMPLANT. VERIFICATION OF THE IMPLANT CODE WAS MADE WITH THE PATIENT'S IDENTIFICATION, INTRA-SURGICALLY IT IS EVIDENT THAT THE PERSONALIZED IMPLANT DOES NOT ADAPT CORRECTLY TO THE BONE DEFECT. IN THE POSTERIOR TEMPORAL PART, IT IS TOO PROMINENT AND DID NOT MATCH THE CONCAVITIES, IN THE UPPER FRONT PART IT WAS ELEVATED. THE SURGEON PERFORMS RELEASE AND GREATER EXPOSURE OF THE BONE TO TRY TO ADAPT THE IMPLANT BUT, AT THE TIME OF UNION IN THE FRONT PART ROSE IN THE TEMPORAL AND VISCERAL PARTS. THE SPECIALIST SAYS THAT THE IMPLANT FEELS TOO THICK COMPARING IT WITH OTHER IMPLANTS THAT IT HAD PLACED. THE SURGEON STATES THAT THE EDGES OF THE IMPLANT MUST BE MILLED AND RESHAPED, APPROXIMATELY 4 MM OF EACH SIDE WAS CUT. THE PEEK IMPLANT ACHIEVED BETTER ADAPTATION OF THE IMPLANT AND IS FIXED WITH 7 PLATES AND THEIR RESPECTIVE SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ONE HUNDRED FIFTY (150) MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE/S

  Patient problems: No Code Available

  MAUDE report 8757685 ↗
• InjuryMar 7, 2019Adverse 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 REMOVAL OF THE PEEK IMPLANT DUE TO SOFT TISSUE BREAKDOWN. ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THE IMPLANT WAS COMPLETELY FINE AND STILL INTACT. THE DEVICE WAS REMOVED; THE SOFT TISSUE BREAKDOWN WAS DEALT WITH AND THE DEVICE WAS IMPLANTED AGAIN. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Tissue Damage

  MAUDE report 8401227 ↗
• InjuryFeb 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 13, 2017 FURTHER REPORTING THAT THE PATIENT UNDERWENT HARDWARE EXPLANT SURGERY ON (B)(6) 2017 DUE TO INFECTION. A CRANIAL PATIENT SPECIFIC IMPLANT (PSI), THREE (3) TITANIUM STRAIGHT PLATES, AND SIX (6) 4 MM TITANIUM SELF-DRILLING SCREWS WHERE INITIALLY IMPLANTED ON (B)(6) 2016 AND WERE ALL REMOVED DURING THE (B)(6) 2017 SURGERY. THE PATIENT WILL UNDERGO SURGERY TO IMPLANT A NEW PSI AND ASSOCIATED HARDWARE ON AN UNKNOWN FUTURE DATE. THIS REPORT IS 1 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 6294191 ↗