FLOWERS MANDIBULAR GLOVE

Additional Manufacturer Narrative

THE ACTUAL DEVICE WAS RETURNED AND THE DEVICE SHOWED APPARENT PHYSICIAN MODIFICATION VIA CARVING/TRIMMING ALONG THE SUPERIOR EDGE AND LATERAL ARMS. IN ADDITION, THREE OTHER OPENINGS WERE FOUND WITH EDGE PATTERNS CHARACTERISTIC OF SHARP INSTRUMENT DAMAGE, THOUGH OPENINGS MAY HAVE BEEN EXTENDED VIA TEARING. PRODUCT LABELING WARNS THAT UTMOST CARE SHOULD BE TAKEN TO PREVENT IMPLANT DAMAGE DURING HANDLING OR SURGERY. LABELING ALSO INDICATES THAT THE PROPER SIZE AND SHAPE OF IMPLANTS MUST BE DETERMINED FOR THE INDIVIDUAL PATIENT BY THE SURGEON.

Description of Event or Problem

COMPLAINT REPORTED THAT THE DOCTOR COULD NOT GET THE DEVICE TO LIE FLUSH, AND WHILE HE WAS WORKING ON IT, IT SPLIT IN THE MIDDLE. ADDITIONAL INFORMATION WILL BE REQUESTED. THE DOCTOR PROCEEDED WITH ANOTHER DEVICE.