{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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PROVIDED RADIOGRAPHS IDENTIFIED A DISLODGMENT OF THE INTERVERTEBRAL CAGE AT L5-S1 INTO THE SPINAL CANAL. BONE QUALITY WAS NORMAL. NO DEFINITE ABNORMALITY SEEN WITHIN THE PATIENT'S ANATOMY OR PRODUCT POSITION THAT COULD EXPLAIN THE DISLOCATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. REPORT SOURCE: EVENT OCCURRED IN (B)(6)." }, { "mdr_text_key": "191916188", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS POST IMPLANTATION, THE PATIENT EXPERIENCED A DISLOCATION OF THE INTERBODY DEVICE ON THE L5-S1 VERTEBRAE. PATIENT WAS ASYMPTOMATIC, HOWEVER, THE CAGE WAS REMOVED. 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