inforMED
InjuryKGS

PANALOK ANCHOR

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

Report 1221934-2005-00180 · MDR key 641324

Device

Generic name

Soft Tissue Fixation Device

Manufacturer

Depuy Mitek

Model number

UNK

Catalog number

UNK PANALOK

Lot number

UNK

Product problems

  • Implant, removal of

Patient

57 YR

  • Fever
  • Fistula
  • Granuloma
  • Surgical procedure, repeated
  • Tissue Damage
  • Reaction

Narrative

Description of Event or Problem

OUR AFFILIATE IS REPORTING A WOMEN HAD SURGERY IN 2005, FOR DRAINAGE OF CALCAREOUS TENDONITIS. USED 1 PANALOK FOR THE REPAIRING OF THE DRAINAGE SITE. WHICH WAS VERY LARGE. BY 2005 THE PT WAS EXPERIENCING SOME REACTIONS; A FISTULA AND SOME FEVER. AFTER A FEW DAYS THE FISTULA CLOSED, HOWEVER, A FEW DAYS LATER THE CONDITION RETURNED. SAMPLES FROM A SECRETION AT THE FISTULA WERE TAKEN AND FOUND TO BE PSEUDOMONAS. IN 2005 A RE-OPERATION WAS PERFORMED TO REMOVE THE ANCHOR, WHICH WAS UNTIED(?) AND THE SURGEON PERFORMED SCAR DEBRIDEMENT. AT THE TIME THE SURGEON NOTED THAT THE PT HAD DAMAGE TO THE HUMERUS [MAJOR TUBERCLE]. SOME MATERIAL WAS CULTURED AND THERE WAS NO BACTERIAL GROWTH FOUND. GRANULOMA FOUND. CURRENTLY THE PT IS WELL, NO FEVER AND NO FISTULA.