DUO HEADLIGHT 2 BAY SYSTEM - US

Additional Manufacturer Narrative

UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). DUO HEADLIGHT WAS NOT RETURNED (CUSTOMER DECLINED TO RETURN THE PRODUCT FOR FAILURE ANALYSIS); THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Additional Manufacturer Narrative

ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

A FACILITY REPORTED THE DUO HEADLIGHT WAS USED FOR A SPINAL DECOMPRESSION ON (B)(6) 2020. THE SURGEON STARTED GETTING HEADACHE 30 MINUTES INTO THE CASE AND USED THE UNIT FOR A TOTAL OF ONE (1) HOUR BEFORE HAVING TO TAKE OFF AND ADJUST TO A THINNER 1.5 LED PADDING WITH NO IMPROVEMENT. THE SURGEON SAID THAT THE PADDING IN FRONT WAS PRESSING AGAINST HIS TEMPLES JUST ABOVE HIS EYEBROWS AND THOUGHT THAT THE DUO BALANCE WAS MORE FRONT LOADED FEELING LIKE THE HEADLIGHT WOULD CONTINUE TO COME FORWARD. THE SURGEON RATED HIS HEADACHE AS 7 FROM A SCALE OF 1 TO 10, AND FELT BETTER WHEN HE TOOK OFF THE DUO HEADLIGHT..