OtherKGS
CORKSCREW SUTURE ANCHOR W/TWO #2 FIBERWIRE, 5.0MM
Received Dec 20, 2004 · Event occurred Dec 1, 2004
Report 1220246-2004-00166 · MDR key 561804
Device
Generic name
Suture Anchor Device
Manufacturer
Arthrex, Inc.Model number
AR-1920SFCatalog number
AR-1920SF
Lot number
37244
Product problems
- Unknown (for use when the device problem is not known)
Patient
*
- Reaction
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PT HAD A REACTION 2 WEEKS POST OP. ALL CULTURES TAKEN FROM THE PT WERE NEGATIVE. THIS PT HAD A ROTATOR CUFF REPAIR A FEW YEARS BACK AND PRESENTED THE SAME TYPE OF REACTION. THE SURGEON BELIEVES THAT THIS PT IS HAVING A REACTION TO THE TITANIUM. THE PT WAS BROUGHT IN AND THE WOUND WAS FLUSHED AND DRAINED. THE PT WAS PUT ON ANTIBIOTICS AND THERE IS NO PLANS TO REMOVE THE IMPLANTS (X2) AT THIS TIME. THIS DEVICE IS USED FOR TREATMENT.