Guided Growth Plate System 1 (REF 99-GP224CE)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18033509852640), received between Mar 17, 2017 and Mar 17, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 16, 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.

• MalfunctionMar 17, 2017Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99-GP224CE (EIGHT PLATE SCREW 24 MM STERILE); BATCH NUMBER: V1333751; QUANTITY: 1; HOSPITAL NAME: (B)(6); SURGEON NAME: DR. (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2013 ((B)(6) HOSPITAL); BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR; SURGERY DESCRIPTION: CORRECTION; PATIENT INFORMATION: (B)(6) WITH ARTHROGRYPOSIS MULTIPLEX CONGENITAL; PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: "THE OPERATION OF EIGHT PLATE SYSTEM WAS CARRIED OUT FOR A PATIENT OF CONGENITAL MULTIPLE ARTHROGRYPOSIS ON (B)(6) 2013. ABNORMALITY WAS NOT FOUND BY THE FOLLOW-UP OF (B)(6) 2016, BUT THE SURGEON FOUND THE BREAKAGE OF THE SCREW OF THE PROXIMAL PART OF THE INNER SIDE OF THE DISTAL SIDE OF THE FEMUR BY FOLLOW-UP OF (B)(6) 2017. THE SURGEON OPERATED FOR THE REMOVAL OF THE IMPLANT ON (B)(6) 2017. HOWEVER, S/HE DECIDED TO LEAVE IT IN THE BODY OF THE PATIENT BECAUSE THE SURGEON WAS NOT ABLE TO REMOVE THE BROKEN TIP. THE SURGEON ASKED (B)(6) FOR THE CAUSE INVESTIGATION THAT THE SCREW WAS BROKEN. (B)(6) CONFIRMED THE RETURN PRODUCT WAS BROKEN. WHEN WE OBSERVED THE BROK

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6412518 ↗