AccuShapeRecalls & reported problems across all models

We found 8 models of AccuShape by Medcad in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Mar 31, 2020 and Sep 28, 2026 — classified as 32 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AccuShape problems

AccuShape models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AccuShape® MC-SPK30

  Plate, Cranioplasty, Preformed, Non-Alterable
  13 reports
• AccuShape® MC-SPK40

  Plate, Cranioplasty, Preformed, Non-Alterable
  13 reports
• AccuShape® ZB-SPK30

  Plate, Cranioplasty, Preformed, Non-Alterable
  3 reports
• AccuShape® MC-SPK10

  Plate, Cranioplasty, Preformed, Non-Alterable
  2 reports
• AccuShape® MC-SPK20

  Plate, Cranioplasty, Preformed, Non-Alterable
  2 reports
• AccuShape® ZB-SPK40

  Plate, Cranioplasty, Preformed, Non-Alterable
  2 reports
• AccuShape® ACSX-004

  Plate, Cranioplasty, Preformed, Non-Alterable
  1 report
• AccuShape® ZB-SPK20

  Plate, Cranioplasty, Preformed, Non-Alterable
  1 report

Recent AccuShape adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionApr 17, 2026Failure to Clean Adequately

  PEEK IMPLANT HAD SHEEN ON IT AND DRAINAGE HOLES WERE NOT CLEANED ALL THE WAY THROUGH.

  Patient problems: Failure of Implant

  MAUDE report 24913032 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  CRANIAL DEVICE EXPLANT.

  Patient problems: Wound Infection

  MAUDE report 24252208 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRANIAL DEVICE EXPLANT.

  Patient problems: Hematoma

  MAUDE report 23006366 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRANIAL DEVICE EXPLANT DUE TO PATIENT'S CONTINUED GROWING TUMOR POST-OPERATIVELY. IMPLANT TO BE EXPLANTED AND REPLACED FOLLOWING ADDITIONAL SURGICAL DEFECT REMOVAL.

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

  MAUDE report 22913825 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRANIAL DEVICE EXPLANT.

  Patient problems: Medical device site infection

  MAUDE report 22741739 ↗
• InjuryJul 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  EXPLANT.

  Patient problems: Insufficient Information

  MAUDE report 22568427 ↗
• 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 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A BLOOD CLOT, THEY HAD TO REMOVE THE IMPLANT TO ACCESS.

  Patient problems: Insufficient Information

  MAUDE report 21968674 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED MEDICAL EVENT REQUIRING EXPLANT.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 21719149 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD CANCER RETURN HAD EXTENSIVE RADIATION ON THE AREA CAUSING BONE FLAP DEATH AND INFECTION. IMPLANT WAS REMOVED AND REPLACED FOLLOWING ADDITIONAL SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21698637 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT TUMOR CONTINUED GROWING POST-OPERATIVELY. IMPLANT TO BE REMOVED AND REPLACED FOLLOWING ADDITIONAL SURGICAL DEFECT REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 21439787 ↗
• 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 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 20632821 ↗