inforMED
InjuryKGS

PANALOK ANCHOR

Received Oct 14, 2005 · Event occurred Sep 21, 2005

Report 1221934-2005-00179 · MDR key 641293

Device

Generic name

Soft Tissue Fixation Device

Manufacturer

Depuy Mitek

Model number

UNK

Catalog number

PANALOK

Lot number

UNK

Product problems

  • Other (for use when an appropriate device code cannot be identified)

Patient

48 YR

  • Fever
  • Scar Tissue
  • Reaction

Narrative

Description of Event or Problem

OUR AFFILIATE IS REPORTING THAT A WOMEN HAD SURGERY, ROTATOR CUFF REPAIR, IN 2005. 3 DEPUY MITEK PANALOK ANCHORS WERE USED FOR REPAIR. BY 2005 THE PT EXPERIENCED SOME REACTIONS, A FISTULA AT THE LATERAL PORT, SOME FEVER, WITHOUT GROWTH OF BACTERIUM IN THE SECRETION. AFTER 3 WEEKS FISTULA CLOSED, HOWEVER THERE IS SOME SCARING.