LATTUS

Additional Manufacturer Narrative

THE DISTRIBUTOR REPORTEDLY RETURNED THE SET BUT DID NOT USE THE MANUFACTURER PROVIDED SHIPPING LABEL AND WAS UNABLE TO PROVIDE TRACKING INFORMATION. THE DISTRIBUTION CENTER COULD NOT CONFIRM RECEIPT OF THE DEFECTIVE COMPONENT, AND EVALUATION WAS NOT PERFORMED. NO PATIENT INJURY OCCURRED, AND SURGERY WAS COMPLETED SUCCESSFULLY. THIS EVENT IS BEING REPORTED DUE TO THE SIGNIFICANT SURGICAL DELAY. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

Description of Event or Problem

A PATIENT UNDERWENT LATERAL SPINE SURGERY ON (B)(6) 2025 UTILIZING SEASPINE/ORTHOFIX'S LATTUS LATERAL ACCESS SYSTEM. DURING THE PROCEDURE, THE SHIM INSERTER FAILED TO REMOVE THE SHIM, RESULTING IN A DELAY OF APPROXIMATELY TWO HOURS. NO BACKUP INSTRUMENT WAS AVAILABLE, AND THE SHIM WAS ULTIMATELY REMOVED BY FORCE. THE DEVICE WAS IN CONTACT WITH THE PATIENT; HOWEVER, NO PATIENT INJURY, ADDITIONAL TREATMENT, OR DEATH WAS REPORTED. THIS EVENT IS BEING SUBMITTED DUE TO THE SIGNIFICANT SURGICAL DELAY.