OPS

Additional Manufacturer Narrative

WE ARE CURRENTLY IN THE PROCESS OF RETRIEVING FURTHER INFORMATION TO PERFORM INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

Description of Event or Problem

REVISION DUE TO DISLOCATION.

Additional Manufacturer Narrative

(B)(4) FINAL REPORT: AN INVESTIGATION WAS LAUNCHED INTO THIS EVENT BY THE MANUFACTURER. A REVIEW OF PRODUCT HISTORY RECORDS WAS PERFORMED WHICH REVEALED THAT NO ANOMALIES WERE OBSERVED IN THE DEVICE HISTORY RECORDS OF OPS INSIGHT WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE OPS PLAN WAS MADE IN ACCORDANCE WITH SPECIFICATION. THERE IS NO INDICATION THAT OPS WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE AVAILABLE INFORMATION, THE MANUFACTURER HAS CONCLUDED THAT THIS EVENT WAS UNRELATED TO THE USE OF OPS TECHNOLOGY AND THE ROOT CAUSE REMAINS UNDETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE IS SYSTEMATIC. THEREFORE, NO FURTHER CORRECTIVE OR PREVENTIVE ACTION IS DEEMED NECESSARY. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

Description of Event or Problem

REVISION DUE TO DISLOCATION AND INSTABILITY.