inforMED
InjuryGXN

ACCUSHAPE PEEK

Received Feb 3, 2026

Report 3009196021-2026-00002 · MDR key 24252208

Device

Generic name

Peek Cranial Implant

Manufacturer

Medcad

Model number

MC-SPK30

Catalog number

MC-SPK30

Lot number

251742LOW

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

74 YR · Male

  • Wound Infection

Narrative

Additional Manufacturer Narrative

AT THE TIME OF INVESTIGATION THE SALES REP. (B)(6) WASN'T CERTAIN ABOUT WHEN WILL THE REVISION SURGERY TAKE PLACE.

Description of Event or Problem

CRANIAL DEVICE EXPLANT.