AccuShape® ZB-SPK30Recalls & reported problems
Medcad · PEEK Cranial Implant, Large · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810007630625), received between May 3, 2024 and Apr 17, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Clean Adequately” (1 report).
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 Problem2
- Failure to Clean Adequately1
Patient problems
- Failure of Implant1
- Insufficient Information1
- Post Operative Wound Infection1
- Tissue Breakdown1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT EXPERIENCED INFECTION AT THE ORIGINAL INCISION SITE DUE TO TISSUE BREAKDOWN FROM POST-OPERATIVE RADIATION. AS A RESULT, THE IMPLANT WAS EXPLANTED.
Patient problems: Post Operative Wound Infection; Tissue Breakdown
MAUDE report 19244180 ↗
Other Plate, Cranioplasty, Preformed, Non-Alterable devices
- NA SD800.440Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE22 reports
- AccuShape® MC-SPK30Medcad · Plate, Cranioplasty, Preformed, Non-Alterable13 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.