NA 1895-5001SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540202109), received between Jun 28, 2018 and Jun 18, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Device Dislodged or Dislocated

  POSTOPERATIVE X-RAY REVEALED THAT THE CONDYLE SCREW NUT HAD DISLOCATED.

  Patient problems: Insufficient Information

  MAUDE report 25543090 ↗
• InjuryJan 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "A PATIENT UNDERWENT AN ORIF FOR DISTAL FEMUR ON (B)(6) 2020. ON UNKNOWN DATE, TWO SCREWS OF CONDYLE CAME OFF AND THE PATIENT HAD REVISION SURGERY ON (B)(6) 2020."

  Patient problems: Failure of Implant

  MAUDE report 11113751 ↗
• InjuryJan 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "A PATIENT UNDERWENT AN ORIF FOR DISTAL FEMUR ON (B)(6) 2020. ON UNKNOWN DATE, TWO SCREWS OF CONDYLE CAME OFF AND THE PATIENT HAD REVISION SURGERY ON (B)(6) 2020."

  Patient problems: Failure of Implant

  MAUDE report 11113676 ↗
• MalfunctionJun 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: SUPRACONDYLAR FRACTURE OF THE FEMUR (RIGHT). T2SCN. THE NUT ON THE CONDYLE SCREW CAME OUT ONE WEEK AFTER THE OPERATION. THERE WAS NO PROBLEM WITH THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10209224 ↗
• InjuryJun 28, 2018Bent; Break

  IT WAS REPORTED THAT AFTER THE FIRST REVISION SURGERY((B)(6) 2018), BREAKAGE OF THE SCREW WHICH WAS REPLACED IN THE REVISION SURGERY AND MOST PROXIMAL CONDYLAR SCREW WERE FOUND ON (B)(6) 2018. REVISION REPORTED UNDER PI (B)(4). SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 AND BREAKAGE OF THE ALL OF IMPLANTED SCREWS WERE FOUND DURING THE REVISION SURGERY. IN THE SECOND REVISION SURGERY, ALL OF THE IMPLANTS INCLUDING THE NAIL WERE REPLACED.

  Patient problems: No Code Available

  MAUDE report 7648631 ↗
• InjuryJun 28, 2018Bent

  IT WAS REPORTED THAT AFTER THE FIRST REVISION SURGERY((B)(6) 2018), BREAKAGE OF THE SCREW WHICH WAS REPLACED IN THE REVISION SURGERY AND MOST PROXIMAL CONDYLAR SCREW WERE FOUND ON (B)(6) 2018. REVISION REPORTED UNDER PI (B)(4). SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 AND BREAKAGE OF THE ALL OF IMPLANTED SCREWS WERE FOUND DURING THE REVISION SURGERY. IN THE SECOND REVISION SURGERY, ALL OF THE IMPLANTS INCLUDING THE NAIL WERE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7648629 ↗