inforMED
MalfunctionLRY

OSSIO PUNCH

Received Jun 4, 2026 · Event occurred Mar 3, 2025

Report MW5188937 · MDR key 25391791

Device

Generic name

Punch, Surgical

Manufacturer

Ossio Ltd.

Lot number

OF05046

Patient

49 YR · Unknown

  • Hypersensitivity/Allergic reaction
  • Inflammation
  • Pain
  • Impaired Healing
  • Osteopenia/ Osteoporosis
  • Swelling/ Edema

Narrative

Description of Event or Problem

I WENT INTO SURGERY TO HAVE A BAKERS CYST REMOVED. I AWOKE FROM SURGERY IN EXTREME PAIN AND WAS NEVER INFORMED OR CONSENTED TO HAVING MULTIPLE DEVICES IMPLANTED. I ONLY KNOW ABOUT THEM NOW DUE TO COMPLICATIONS WITH PAIN, SWELLING, ALLERGIC AND INFLAMMATORY REACTION THAT HASN'T HEALED. MY FEMUR IS EXPERIENCING POST OPERATIVE OSTEOPENIA AND THE MARROW HAS BEEN DESCRIBED AS YELLOW AND HAZY. ADDITIONAL PRODUCT DETAILS: I AM INCLUDING A COPY OF THE MEDICAL RECORD GIVEN TO ME BY INTEGRIS.