InjuryLYT
CAGE
Received Jan 3, 2013
Report 2520274-2013-00058 · MDR key 2895790
Device
Generic name
Cage
Manufacturer
Synthes UsaProduct problems
- Positioning Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH CAGE ON AN UNKNOWN DATE. AFTER 3 MONTHS (POST OP CONTROL) THE CAGE IS SINKED.
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.