AccuShape® ZB-SPK40Recalls & reported problems

Medcad · PEEK Cranial Implant, Extra Large · 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 00810007630632), received between Aug 26, 2024 and Aug 7, 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

Medical device site infection1
Post Operative Wound Infection1
Unspecified Infection1

Recent adverse event reports

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

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 ↗
InjuryAug 26, 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: Post Operative Wound Infection; Unspecified Infection
MAUDE report 20064839 ↗

Device details

UDI-DI	`00810007630632`
Brand	AccuShape®
Model	ZB-SPK40
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	May 13, 2022

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.

Other Plate, Cranioplasty, Preformed, Non-Alterable devices

NA SD800.440
Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
22 reports
AccuShape® MC-SPK30
Medcad · Plate, Cranioplasty, Preformed, Non-Alterable
13 reports
AccuShape® MC-SPK40
Medcad · Plate, Cranioplasty, Preformed, Non-Alterable
13 reports
NA SD800.434
Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
11 reports
NA SD800.433
Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
8 reports
NA SD800.427
Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
8 reports
IPS 60-000-23-09
KLS-Martin L.P. · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
7 reports
NA SD800.540
Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
6 reports

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.