InjuryKGS
PANALOK ANCHOR
Received Oct 14, 2005 · Event occurred Sep 21, 2005
Report 1221934-2005-00181 · MDR key 641287
Device
Generic name
Soft Tissue Fixation Device
Manufacturer
Depuy MitekModel number
UNKCatalog number
UNK PANALOK
Lot number
UNK
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
43 YR
- Fever
- Fistula
- Post Operative Wound Infection
Narrative
Description of Event or Problem
OUR AFFILIATE IS REPORTING THAT A PT HAD A SURGERY, FOR ROTATOR CUFF REPAIR IN 2005. ONE PANALOK WAS USED IN THE REPAIR. BY 2005 THE PATIENT HAD A FEVER AND A FISTULA AT THE OP AREA, THE FISTULA WAS DRAINED. THE DRAINED FLUID WAS CULTURED AND FOUND TO BE PSEUDOMONAS PUTREFACIENS. THERE WAS NO BONE DESTRUCTION AND AN MRI REVEALED NO FLUID COLLECTION.