MalfunctionGEY
LINDEMANN BURR 1.5X14X70MM
Received Jun 26, 2017 · Event occurred May 30, 2017
Report 2916714-2017-00013 · MDR key 6667698
Device
Generic name
High Speed Power Systems
Manufacturer
Orchid Unique Orthopedic SolutionsModel number
MD754Catalog number
MD754
Product problems
- Break
- Break
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT DURING THE EEC OPERATION A BROKEN PART WAS LEFT IN THE ORAL CAVITY. THIS MISSING/BROKEN PART WAS FOUND BY USING A X-RAY AND REMOVED FROM THE PATIENT. THE SURGICAL DELAY IS UNKNOWN.