6257 XPEDITION HIGH CONFIG

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE IS PENDING EVALUATION. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS): 1 DEVICE: APPROPRIATE TERM/CODE NOT AVAILABLE / RESULTS PENDING COMPLETION OF INVESTIGATION THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

Description of Event or Problem

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED SEAT SECTION UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Additional Manufacturer Narrative

1 DEVICE WAS NOT EVALUATED AS THE CAUSE WAS DETERMINED BY ANALYZING DATA PROVIDED BY THE USER/THIRD PARTY; NO FURTHER ASSISTANCE WAS REQUESTED BY THE CUSTOMER. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS). 1 DEVICE: FASTENER/DEVICE MIGRATION.

Description of Event or Problem

NO NEW INFORMATION.