MalfunctionKGS
STATAK SOFT TISSUE ATTACHMENT ANCHOR
Received Sep 7, 2012 · Event occurred Aug 8, 2012
Report 1822565-2012-01874 · MDR key 2743449
Device
Product problems
- Detachment Of Device Component
Patient
59 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT IS REPORTED THAT THE STATAK DEVICE WAS INSERTED AND THE ETHIBOND SUTURE WAS FRAYED WHERE IT ATTACHES TO THE DEVICE. THE SURGEON WAS UNABLE TO REMOVE THE ANCHOR.
Additional Manufacturer Narrative
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.