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 MitekModel number
UNKCatalog 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.