NA 214.038Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982153517), received between Sep 10, 2018 and Sep 10, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT WAS TREATED WITH DISTAL FEMUR FRACTURE SYSTEM DUE TO COMPLEX FRACTURE. ON (B)(6) 2018, PATIENT SUFFERED PAIN DUE TO A BODY-HEIGHT FALL. MEDICAL IMAGE EXAMINATION ON AN UNKNOWN DATE INDICATED THAT THERE WERE BROKEN SCREWS AS WELL AS A DELAYED CONSOLIDATION OF THE FRACTURE. REVISION SURGERY FOR THE REMOVAL OF IMPLANT AND PLACING OF A NEW ONE IS CURRENTLY UNSCHEDULED. PATIENT REQUESTED A VOLUNTARY DISCHARGE AND CAN NO LONGER BE CONTACTED. CONCOMITANT DEVICES: TRAUMA PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), TRAUMA SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 4.5MM CORTEX SCREW 38MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Impaired Healing; Pain

  MAUDE report 7861338 ↗
• InjurySep 10, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT WAS TREATED WITH DISTAL FEMUR FRACTURE SYSTEM DUE TO COMPLEX FRACTURE. ON (B)(6) 2018, PATIENT SUFFERED PAIN DUE TO A BODY-HEIGHT FALL. MEDICAL IMAGE EXAMINATION ON AN UNKNOWN DATE INDICATED THAT THERE WERE BROKEN SCREWS AS WELL AS A DELAYED CONSOLIDATION OF THE FRACTURE. REVISION SURGERY FOR THE REMOVAL OF IMPLANT AND PLACING OF A NEW ONE IS CURRENTLY UNSCHEDULED. PATIENT REQUESTED A VOLUNTARY DISCHARGE AND CAN NO LONGER BE CONTACTED. CONCOMITANT DEVICES: TRAUMA PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN); TRAUMA SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 4.5MM CORTEX SCREW 38MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Impaired Healing; Pain

  MAUDE report 7861306 ↗