NA SD800.434Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10887587064772), received between Nov 19, 2018 and Oct 4, 2024 — classified as 10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY, JUST THE EXTRA SURGERY FOR REMOVAL.

  Patient problems: Unspecified Infection

  MAUDE report 20369336 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED REVISION SURGERY OCCURRED ON (B)(6) 2024 AND THE DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 18703574 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED REVISION SURGERY OCCURRED ON (B)(6) 2024 AND THE DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 18703527 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE IMPLANT IN QUESTION HAD TO BE REMOVED DUE TO A SCALP INFECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAYS. THIS REPORT IS FOR A PSI SD800.434 PEEK IMPLANT. THIS IS REPORT 1 OF 14 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14873875 ↗
• MalfunctionMar 2, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PSI GROUP FAILED TO MAKE 3MM HOLES. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICES UNK - PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652853 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED POST-OP INFECTION. THE PATIENT RECEIVED THE IMPLANTS ON (B)(6) 2019. ON (B)(6) 2021 THE PATIENT UNDERWENT IMPLANT REMOVAL SURGERY. THIS REPORT INVOLVES ONE (1) PSI SD800.434 PEEK IMPLANT. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11685341 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED POST-OP INFECTION. THE PATIENT RECEIVED THE IMPLANTS ON (B)(6) 2019. ON (B)(6) 2021 THE PATIENT UNDERWENT IMPLANT REMOVAL SURGERY. THIS REPORT INVOLVES 1 PSI SD800.434 PEEK IMPLANT. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11685305 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED POST-OP INFECTION. THE PATIENT RECEIVED THE IMPLANTS ON (B)(6) 2019. ON (B)(6) 2021 THE PATIENT UNDERWENT IMPLANT REMOVAL SURGERY. THIS REPORT INVOLVES ONE (1) PSI SD800.434 PEEK IMPLANT. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11685219 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED POST-OP INFECTION. THE PATIENT RECEIVED THE IMPLANTS ON (B)(6) 2019. ON (B)(6) 2021 THE PATIENT UNDERWENT IMPLANT REMOVAL SURGERY. THIS REPORT INVOLVES ONE (1) PSI SD800.434 PEEK IMPLANT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11685135 ↗
• InjuryNov 19, 2018Defective Device; Defective Device

  IT WAS REPORTED ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, IT WAS FOUND OUT THAT THE POLYETHER ETHER KETONE (PEEK) IMPLANTS DID NOT FIT THE DEFECT PROPERLY. IMPLANTS WERE HEAVILY MODIFIED BY SURGEONS IN ORDER TO FIT PATIENT DEFECT. CUTTING AND BURRING OF IMPLANTS WERE DONE TO MAKE THEM FIT. PROCEDURE WAS SUCCESSFULLY COMPLETE WITH A SURGICAL DELAY OF UNKNOWN NUMBER OF MINUTES. THIS REPORT IS FOR ONE (1) PSI SD800.434 PEEK IMPLANT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8087600 ↗
• InjuryNov 19, 2018Defective Device; Defective Device

  IT WAS REPORTED ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, IT WAS FOUND OUT THAT THE POLYETHER ETHER KETONE (PEEK) IMPLANTS DID NOT FIT THE DEFECT PROPERLY. IMPLANTS WERE HEAVILY MODIFIED BY SURGEONS IN ORDER TO FIT PATIENT DEFECT. CUTTING AND BURRING OF IMPLANTS WERE DONE TO MAKE THEM FIT. PROCEDURE WAS SUCCESSFULLY COMPLETE WITH A SURGICAL DELAY OF UNKNOWN NUMBER OF MINUTES. THIS REPORT IS FOR ONE (1) PSI SD800.434 PEEK IMPLANT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8087596 ↗