AccuShape® MC-SPK10Recalls & reported problems

Medcad · PEEK Cranial Implant, Small · Class 2 · Implant

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810007630090), received between Feb 21, 2025 and Mar 26, 2025 — classified as 2 injuries.

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem2

Patient problems

Insufficient Information2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

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 ↗

Device details

UDI-DI	`00810007630090`
Brand	AccuShape®
Model	MC-SPK10
Company	Medcad
Product code	GXN · Plate, Cranioplasty, Preformed, Non-Alterable
Class	Class 2
FDA submission	K110684
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 11, 2019

Device type (GMDN): Cranioplasty plate, non-alterable

An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

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All Plate, Cranioplasty, Preformed, Non-Alterable devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.