Guided Growth Plate System 1 (REF 99-GP400CE)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18033509852657), received between Jun 6, 2022 and Jun 6, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2022Break; Use of Device Problem; Break; Use of Device Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: UNKNOWN. DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT LATERAL TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: (B)(6) YEAR-OLD. PROBLEM OBSERVED DURING: INTO TREATMENT. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: EIGHT-PLATE" WAS PLACED ON THE TIBIA FOR "LEFT THIGH TIBIAL END GROWTH INHIBITION SURGERY" AND RADIOGRAPHS WERE TAKEN ABOUT EIGHT MONTHS LATER, WHICH REVEALED A BROKE IN THE CENTER OF THE "EIGHT PLATE". EXTRACTION SURGERY WAS PERFORMED TO REMOVE THE RUPTURED PLATE. THE DATE OF THE DAMAGE IS UNKNOWN, BUT THE DAMAGE WAS DISCOVERED ON (B)(6) 2022. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED: (B)(6) 2022. A MEDICAL INTERVENTION WAS REQUIRED. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE SO FAR. PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 14602189 ↗