InjuryKGS
SDI SUTURE ANCHOR 3.0MM INST.
Received Sep 15, 2005 · Event occurred Jul 5, 2005
Report 1219930-2005-00315 · MDR key 635249
Device
Generic name
Suture Anchor
Manufacturer
North Haven - UssModel number
*Catalog number
2730247
Lot number
N4F340
Product problems
- Replace
- Suture line separation
Patient
UNKNOWN
- Wound Dehiscence
- Pain
- Surgical procedure
- Reaction
- Drainage
Narrative
Description of Event or Problem
REPORTEDLY, THE PATIENT EXPERIENCED PAIN POST OPERATIVELY 2-3 WEEKS AFTER PROCEDURE. THE WOUND BEGAN TO DRAIN SO THEY TOOK THE PATIENT IN FOR FOLLOW-UP SURGERY. THEY FOUND THAT THE REPAIR HAD COME UNDONE AND THAT THERE WAS A REACTION. GRAINY SUBSTANCE WHERE THE BONE HAD BEEN AROUND THE ANCHOR WAS OBSERVED. THERE WERE NO ANTIBIOTICS INTRODUCED AND THERE WERE SWABS TAKEN FOR TEST CULTURES WHICH CAME BACK NEGATIVE. THE AREA WAS CLOSED AND REPAIRED WITH OTHER ANCHORS.