MAYFIELD SWIVEL HORSESHOE HEADREST

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

THIS IS 2 OF 4 REPORTS FOR THE MAYFIELD SYSTEM LINKED TO MFG REPORT NUMBERS: 3004608878-2025-00148, 3004608878-2025-00150, 3004608878-2025-00151. A FACILITY REPORTED THAT THE MAYFIELD SWIVEL HORSESHOE HEADREST (A1012) NEEDS TO BE CHECKED AS IT GOT LOOSE/BECAME UNLOCKED DURING SURGERY, RESULTING IN WHIPLASH FOR THE PATIENT. IT IS UNCLEAR IF THE EVENT LED TO INCREASED SURGERY TIME. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE MAYFIELD SWIVEL HORSESHOE HEADREST (A1012) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - THE DHR WAS REVIEWED AND SHOWS NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. FAILURE ANALYSIS - THE CUSTOMER'S STATEMENT IS CONFIRMED AS VALID AFTER EVALUATING THE DEVICE. THE INSPECTION OF THE MAYFIELD HORSESHOE A1012 WITH THE SERIAL NUMBER (B)(6) SHOWS BOTH THE GEL PADS ARE BROKEN IN SEVERAL PLACES, AND THE SLIDE BAR HAS NO MOVEMENT, AND THE UNIT MUST UNDERGO A FUNCTION TEST AND BE MARKED WITH INSTANCE NUMBER. HOWEVER, THE THREAD AND STARBURST TEETH ARE IN GOOD WORKING ORDER. TO RESOLVE THE ISSUES, THE GEL PADS WERE REPLACED AND MARKED AND THE UNIT HAS BEEN SUBJECTED TO A SUCCESSFUL FUNCTIONAL CHECK TO MEET MANUFACTURER SPECIFICATIONS. ROOT CAUSE - THE COMPLAINT IS CONFIRMED VIA INSPECTION OF THE UNIT. THE GEL PADS WERE BROKEN IN SEVERAL PLACES, AND SLIDE BAR HAD NO MOVEMENT. THE PROBABLE ROOT CAUSE IS DAMAGE TO THE GEL PADS FROM ROUGH OR IMPROPER HANDLING OF THE UNIT. NO CORRECTIVE ACTION HAS BEEN INITIATED FOR THE SAME OR SIMILAR ISSUE. THIS WILL BE MONITORED AND TRENDED GOING FORWARD. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Description of Event or Problem

N/A