Guided Growth Plate System 1 (REF GP400CE)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18054242513353), received between Aug 1, 2022 and Aug 1, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Contamination /Decontamination 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 18, 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.

• InjuryAug 1, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: GP200CE (QTY 1) AND GP400CE (QTY 2) - MFR REPORTS NUMBERS 9680825-2022-00014 AND 9680825-2022-00015 AND 9680825-2022-00016 RESPECTIVELY. BATCH NUMBER: B1275067 AND B1217736. HOSPITAL NAME: (B)(6). SURGEON NAME: DR (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: BOTH LEGS. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: 8 YEARS, FEMALE, 32KG, 124 CM. TYPE OF PROBLEM: CLINICAL (PATIENT) PROBLEM. EVENT DESCRIPTION: "INTRAOPERATIVELY, A BLACK COLOR WAS DETECTED AROUND THE BLUE PLATE". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITION: PATIENT'S HEALTH STATUS IS GOOD AND STABLE. FURTHER INFORMATION RECEIVED ON JULY 26, 2022: THE PROBLEM WAS DETEC

  Patient problems: Metal Related Pathology

  MAUDE report 15137335 ↗
• InjuryAug 1, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: GP200CE (QTY 1) AND GP400CE (QTY 2) - MFR REPORTS NUMBERS 9680825-2022-00014 AND 9680825-2022-00015 AND 9680825-2022-00016 RESPECTIVELY. BATCH NUMBER: B1275067 AND B1217736. HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON NAME: DR (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: BOTH LEGS. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: 8 YEARS, FEMALE, (B)(6) KG, 124 CM. TYPE OF PROBLEM: CLINICAL (PATIENT) PROBLEM. EVENT DESCRIPTION: "INTRAOPERATIVELY, A BLACK COLOR WAS DETECTED AROUND THE BLUE PLATE". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITION: PATIENT'S HEALTH STATUS IS GOOD AND STABLE. FURTHER INFORMATION RECEIVED ON JULY 26, 2022: THE PRO

  Patient problems: Metal Related Pathology

  MAUDE report 15137333 ↗