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MalfunctionGXN

ACCUSHAPE TITANIUM

Received May 22, 2026 · Event occurred Apr 27, 2026

Report 3009196021-2026-00010 · MDR key 25263116

Device

Generic name

Titanium Cranial Implant

Manufacturer

Medcad

Model number

MC-AST40

Catalog number

MC-AST40

Lot number

262859FIT

Product problems

  • Difficult or Delayed Positioning
  • Inadequacy of Device Shape and/or Size

Patient

28 YR · Male

  • Failure of Implant

Narrative

Description of Event or Problem

DISSECTION NEEDED TO MAKE THE IMPLANT FIT, TOOK LONGER THAN EXPECTED.