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BIO-FASTAK SUTURE ANCHOR

Received Jun 10, 2004 · Event occurred Jan 6, 2004

Report 1220246-2004-00002 · MDR key 529140

Device

Generic name

Sutures

Manufacturer

Arthrex, Inc.

Model number

AR-1324BF

Catalog number

AR-1324BF

Lot number

32710

Product problems

  • Explanted

Patient

UNKNOWN

  • Inflammation
  • Pain
  • Swelling
  • Surgical procedure

Narrative

Description of Event or Problem

PT IS HAVING SWELLING, TENDERNESS AND INFLAMMATION 2-3 MONTHS POST-OP.