OtherHSH
OPTETRAK
Received Apr 2, 2013
Report 1038671-2013-00019 · MDR key 3044221
Device
Product problems
- Device Slipped
Patient
Not reported
- Pain
Narrative
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD PROVIDES ASSURANCE THE PART WAS ACCEPTED WITH CONFORMANCE TO THE PRODUCT REQUIREMENTS.
Description of Event or Problem
PRIMARY SURGERY OCCURRED (B)(6) 2008. REVISION DUE TO PAIN AND LOOSENING.