6257 XPEDITION MID CONFIG

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE WAS NOT EVALUATED, AS A PROBABLE CAUSE FOR THE ISSUE WAS IDENTIFIED DURING COMMUNICATION BETWEEN THE CUSTOMER AND STRYKER AND NO FURTHER ASSISTANCE WAS REQUESTED BY THE CUSTOMER. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

Description of Event or Problem

THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED INADEQUATE PATIENT RESTRAINT. THERE WAS NO PATIENT INVOLVEMENT.