OtherKGS
PEBA S 2.8MM PRELOADED ANCHOR
Received Sep 24, 1998 · Event occurred Jul 20, 1998
Report 2028229-1998-00001 · MDR key 189272
Device
Generic name
Soft Tissue Anchor
Manufacturer
Orthopaedic Biosystems Ltd.Model number
NACatalog number
PAS2K
Lot number
A0406B
Product problems
- Explanted
- Replace
Patient
17 YR
- Surgical procedure, repeated
Narrative
Description of Event or Problem
THE PRODUCT (2.8MM SOFT TISSUE ANCHORS) WERE USED IN A BANKHART PROCEDURE. THE SURGEON PLACED THREE ANCHORS IN THE PT AND CLOSED THE SURGICAL SITE. POST OPERATIVE X-RAYS OF THE SURGICAL SITE INDICATED, TO THE SURGEON, ONE ANCHOR WAS LOCATED IN THE SOFT TISSUE AROUND THE GLENOID. THE SURGEON DECIDED TO REVISE THE PLACEMENT OF THE ANCHOR AND REPLACE IT WITH ANOTHER ANCHOR MORE OPTIMALLY PLACED IN THE BONE.
Remedial action
- Replace