AccuShape® MC-SPK40Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00810007630120), received between Aug 19, 2020 and Sep 28, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50915799 ↗
• InjuryJul 8, 2025Prophylactic removal due to corrective action; Prophylactic removal due to corrective action

  PATIENT GOT AN INFECTION THAT REQUIRED THEM TO EXPLANT THE PEEK IMPLANT.

  Patient problems: Wound Infection

  MAUDE report 22444097 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTION. IMPLANT WAS REMOVED.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 21437155 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION, SO THE ORIGINAL IMPLANT WAS EXPLANTED.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 20689255 ↗
• InjuryJun 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION AND THE IMPLANT WAS EXPLANTED AS A RESULT.

  Patient problems: Unspecified Infection

  MAUDE report 17135733 ↗
• InjuryOct 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ACCUSHAPE PEEK CRANIAL IMPLANT WOULD BE EXPLANTED. THE DETAILS AND NATURE OF THE EVENT ARE UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15589364 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT-SPECIFIC CRANIAL IMPLANT WAS EXPLANTED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14024999 ↗
• MalfunctionJan 27, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT-SPECIFIC CRANIAL IMPLANT DID NOT ADEQUATELY FIT THE PATIENT'S CRANIAL DEFECT. ADDITIONAL CRANIAL MESH WAS REQUIRED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366756 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED POST-OPERATIVELY WITH AN UNSPECIFIED INFECTION AND WOULD REQUIRE EXPLANTATION OF THE CRANIAL IMPLANT. .

  Patient problems: Unspecified Infection

  MAUDE report 12674708 ↗
• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SPECIFIC CRANIAL IMPLANT WAS REPORTEDLY EXPLANTED AFTER THE PATIENT PRESENTED AN INFECTION POST-OPERATIVELY.

  Patient problems: Unspecified Infection

  MAUDE report 12071964 ↗
• InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CRANIAL IMPLANT WAS EXPLANTED AFTER THE PATIENT PRESENTED WITH AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10980069 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CRANIAL IMPLANT WAS EXPLANTED AFTER THE PATIENT PRESENTED WITH AN INFECTION POST-OPERATIVELY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10428436 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CRANIAL IMPLANT WAS EXPLANTED AFTER THE PATIENT PRESENTED WITH AN INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10426388 ↗