inforMED
MalfunctionHRS

PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLATE

Received Jan 8, 2016 · Event occurred Aug 31, 2015

Report MW5059224 · MDR key 5360806

Device

Generic name

Bone Plate, Right 73 Mm

Model number

TO-PANTERA

Catalog number

TO-PHP-R73

Lot number

15001131122

Product problems

  • Device Slipped

Patient

56 YR

  • Device Embedded In Tissue or Plaque
  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

DURING A PANTERA SHOULDER SURGERY, A 5.2MM POST SCREW PASSED THRU THE PLATE AND INTO THE BONE. THE POST POSITION WAS NOT PART OF FRACTURE FIXATION. THE SCREW WAS LEFT IN THE PT, NO HARM TO PT. PROLONGED SURGERY LESS THAN 5 MINUTES. REASON FOR USE: BONE FRACTURE.