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Description of Event or Problem

DEVICE REPORT FROM (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT UNDERWENT REMOVAL OF RODS AND SCREWS - T12-S1. REVISION FUSION, REPAIR PSEUDOARTHROSIS L3-L4. RE-INSTRUMENTATION T12-PELVIS ON (B)(6) 2010. THIS IS #6 OF 44 REPORTS FOR THE SAME EVENT.

Additional Manufacturer Narrative

ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT. REPORT ORIGINALLY RECEIVED (B)(4) 2012; FURTHER EVALUATION REVEALED 43 ADDITIONAL DEVICES WITHIN THE REPORTED EVENT WHICH WERE IDENTIFIED ON (B)(4) 2012. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS DEVICE WAS NOT RETURNED AND LOT NUMBER WAS NOT PROVIDED.