TI FIXATION PLATE F/CONDYLAR HEAD/0MM

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW /INVESTIGATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A SURGERY FOR SEGMENTAL MANDIBULECTOMY AND PLATE RECONSTRUCTION. DURING THE SURGERY, THE SURGEON HAD DIFFICULTIES TO INSERTING THE SCREW INTO THE PLATE BECAUSE HE FELT SCREWING WAS QUITE TIGHT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: CONDYLAR HEAD ADD-ON (PART:04.449.000S;LOT# UNKNOWN; QUANTITY: 1), FIXATION PLATE FOR CONDYLAR HEAD (PART:04.449.010S ;LOT# UNKNOWN; QUANTITY: 1), TITANIUM PATIENT SPECIFIC PLATE (PART:SD480.101;LOT# UNKNOWN; QUANTITY: 1), UNK: SCREWDRIVER: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) TITANIUM CONDYLAR HEAD. THIS REPORT IS 2 OF 5 FOR (B)(4).