G-Beam Fusion Beaming System 1 (REF 99-875135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18053504360636), received between Apr 30, 2021 and Apr 30, 2021 — 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.

• InjuryApr 30, 2021Break; Break

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 99-875120 AND 99-875135 (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037 RESPECTIVELY); BATCH NUMBERS: R1226807 AND B1235613 (MFR REPORTS 9680825-2021-00036 AND 9680825-2021-00037 RESPECTIVELY); QUANTITY: 1 EACH; DATE OF INITIAL SURGERY: (B)(6) 2020; BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FOOT; SURGERY DESCRIPTION: CORRECTION; PATIENT INFORMATION: 60 YEARS, MALE, WITH DIABETES AND CHARCOT FOOT; PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: "(B)(6) 2020 - MALE PATIENT, AGE 60 WITH A COLLAPSED FOOT VALVE DUE TO DIABETES. PRETTY GOOD SOFT TISSUES, BUT THE CUBOID BONE HAD STARTED MIGRATING IN PLANTAR DIRECTION. INITIAL PLAN WAS MTP1 FUSION W/ VARIAX PLATE AND 5.4MM G-BEAMS IN 3RD OR 4TH, AND 7.4MM BEAM IN THE SUBTALAR JOINT. AFTER SOME DISCUSSION, THE PLATE WAS SKIPPED AND SURGEON WENT FOR G-BEAMS ALL THE WAY. STATUS OF THE SUBTALAR JOINT WAS PRETTY GOOD, AND NO SUBTALAR FUSION WAS PERFORMED. (B)(6) 2021 - DURING X-RAY INVESTIGATION BREAKAGE OF THE 5.4MM G-BEAMS IN 2ND AND 4TH METATARSAL BONE WAS DISCOVERED. AT THIS POINT

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 11751316 ↗