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AccuShape® MC-SPK20Recalls & reported problems

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

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810007630106), received between Jul 7, 2022 and Jul 12, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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.

Most reported problems

Device problems

  • Difficult or Delayed Positioning1
  • No Apparent Adverse Event1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionJul 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

    THE ANTERIOR CRANIAL IMPLANT DID NOT FIT AS EXPECTED. AS A RESULT, THE ANTERIOR AND POSTERIOR IMPLANTS HAD TO BE MODIFIED TO ALLOW FOR AN ACCEPTABLE FIT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17311203 ↗
  • MalfunctionJul 7, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

    IT WAS REPORTED THAT THE ACCUSHAPE PEEK PATIENT-SPECIFIC IMPLANT WAS MODIFIED TO FIT THE PATIENT'S CRANIAL DEFECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14941179 ↗

Other Plate, Cranioplasty, Preformed, Non-Alterable devices

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.