JUNIORTHO PLATING SYSTEM 1 (REF 99-5415065)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18053800897959), received between Feb 13, 2024 and Feb 13, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionFeb 13, 2024Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODES: 99-5415032 AND 99-5415065 AND 99-5415065 AND 99-5415070 AND 99-5404532 (MFR REPORTS 9680825-2024-00006 AND 9680825-2024-00007 AND 9680825-2024-00008 AND 9680825-2024-00009 AND 9680825-2024-00010 RESPECTIVELY). - BATCH NUMBERS: B1670879 AND B1771062 AND B1771062 AND B4301328 AND B1771063. - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2024. - BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FEMORAL NECK. - SURGERY DESCRIPTION: CORRECTION. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM AND CLINICAL (PATIENT) PROBLEM. - EVENT DESCRIPTION: THE SCREWS ARE DIFFICULT TO ADVANCE INTO THE BONE. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE: OPERATION COMPLETED WITH A COMPETITORS DEVICE. - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 2 HOURS. - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPY OF OPERATIVE REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693546 ↗
• MalfunctionFeb 13, 2024Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODES: 99-5415032 AND 99-5415065 AND 99-5415065 AND 99-5415070 AND 99-5404532 (MFR REPORTS 9680825-2024-00006 AND 9680825-2024-00007 AND 9680825-2024-00009 AND 9680825-2024-00010 RESPECTIVELY). BATCH NUMBERS: B1670879 AND B1771062 AND B1771062 AND B4301328 AND B1771063. HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON'S NAME: DR (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2024. BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FEMORAL NECK. SURGERY DESCRIPTION: CORRECTION. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM AND CLINICAL (PATIENT) PROBLEM. EVENT DESCRIPTION: THE SCREWS ARE DIFFICULT TO ADVANCE INTO THE BONE. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE: OPERATION COMPLETED WITH A COMPETITORS DEVICE. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 2 HOURS. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS AND COPY OF X-RAY IMAGES ARE NOT AVAILA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693545 ↗