CUSHION ASSY SPR-PLUS BOX OF 6

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 2 DEVICES ARE PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

Description of Event or Problem

THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED SAGGING, TOO SOFT, OR NOT FIRM ENOUGH. THERE WERE 2 EVENTS WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

Description of Event or Problem

THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED SAGGING, TOO SOFT, OR NOT FIRM ENOUGH. THERE WERE 2 EVENTS WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

1 DEVICE THAT WAS PENDING EVALUATION WAS NOT MADE AVAILABLE BY THE CUSTOMER; THE REPORTED ISSUE WAS NOT CONFIRMED. 1 PENDING DEVICE WAS NOT EVALUATED, BUT REVIEWED BY DATA AND CONFIRMED THE ISSUE. SECTION H CODES HAVE BEEN UPDATED.