AccuShape® MC-SPK30Recalls & reported problems
Medcad · PEEK Cranial Implant, Large · Class 2 · Implant
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00810007630113), received between Mar 31, 2020 and Feb 3, 2026 — classified as 12 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem10
- Insufficient Device Problem Information3
- Inadequacy of Device Shape and/or Size1
- Migration1
Patient problems
- Unspecified Infection7
- Insufficient Information3
- Post Operative Wound Infection3
- Hematoma1
- No Clinical Signs, Symptoms or Conditions1
- Wound Infection1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
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 ↗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 ↗InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
IMPLANT WAS REMOVED AS A RESULT OF PATIENT'S BRAIN SWELLING.
Patient problems: Insufficient Information
MAUDE report 19226355 ↗InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IMPLANT WAS REMOVED AS A RESULT OF A PATIENT INFECTION.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 18852558 ↗MalfunctionJan 23, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
PATIENT-SPECIFIC PEEK CRANIAL IMPLANT COULD NOT BE IMPLANTED DUE TO FIT ISSUE. FIT ISSUE WAS CAUSED BY NOTICEABLE CEREBRAL/SOFT TISSUE SWELLING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18566683 ↗InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT PRESENTED A POST-OPERATIVE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 16675353 ↗InjuryOct 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT AN INFECTION WAS DETECTED AND THE LEFT-SIDED PEEK CRANIAL IMPLANT HAD TO BE REMOVED.
Patient problems: Post Operative Wound Infection
MAUDE report 15567095 ↗InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CRANIAL IMPLANTS WERE EXPLANTED AFTER THE PATIENT EXPERIENCED AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13358322 ↗InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CRANIAL IMPLANT WAS EXPLANTED AFTER THE PATIENT PRESENTED WITH AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10726983 ↗InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION AT THE IMPLANT SITE AND THAT THE CRANIAL IMPLANT WAS PLANNED TO BE EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9904291 ↗
Other Plate, Cranioplasty, Preformed, Non-Alterable devices
- NA SD800.440Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE22 reports
- AccuShape® MC-SPK40Medcad · Plate, Cranioplasty, Preformed, Non-Alterable13 reports
- NA SD800.434Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE11 reports
- NA SD800.433Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE8 reports
- NA SD800.427Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE8 reports
- IPS 60-000-23-09KLS-Martin L.P. · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE7 reports
- NA SD800.540Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE6 reports
- NA SD800.541Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.