inforMED
MalfunctionMBP

PRIME HD DBM

Received Jun 19, 2020 · Event occurred Jun 11, 2020

Report 10173413 · MDR key 10173413

Device

Generic name

Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

Catalog number

421025

Product problems

  • Material Fragmentation

Patient

8395 DA

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

DURING THE APPLICATION OF PUTTY TO THE RIGHT KNEE, THE APPLICATOR BROKE INSIDE THE PATIENT. ALL VISIBLE PIECES REMOVED BY SURGEON. X-RAYS CLEARED. NO HARM TO PATIENT.