G-Beam Fusion Beaming System 1 (REF 99-187287)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 18053504360766), received between Apr 8, 2019 and Feb 5, 2021 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2021Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: N/A. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: N/A. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: DURING A CASE WITH DR. (B)(6) ON (B)(6) 2021, BOTH WIRES BROKE UPON IMPLANTING. ONE WAS REMOVED FROM THE PATIENT AND ONE WAS LEFT IN THE PATIENT. BOTH BROKE AT THE INDENTATION LINE IN THE WIRE. THE SURGEON DECIDED NOT TO CONTINUE WITH THE USE OF THAT SELECTION. PRODUCT WAS DISCARDED THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. FURTHER INFORMATION RECEIVED ON JANUARY 14TH 2021: THERE WAS NOT AN ADDITIONAL SURGERY REQUIRED TO REMOVE THE FRAGMENT FROM THE PATIENT. THE SURGEON OPTED TO NOT COMPLETE THE PROCEDURE WITH THE REPEATED BREAKAGES. EVENT DESCRIPTION: CHARCOT RECONSTRUCTIVE CASE, (B)(6). 3 - 7.4 G-BEAMS INSERTED 1 WIRE BROKE. WHEN SURGEON WENT TO PLACE IN 5.4MM G-BEAM THE WIRE BROKE OFF INSIDE THE PATIE

  Patient problems: Foreign Body In Patient

  MAUDE report 11284172 ↗
• MalfunctionFeb 5, 2021Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: N/A. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: N/A. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM EVENT DESCRIPTION: DURING A CASE WITH DR. (B)(6) ON (B)(6) 2021, BOTH WIRES BROKE UPON IMPLANTING. ONE WAS REMOVED FROM THE PATIENT AND ONE WAS LEFT IN THE PATIENT. BOTH BROKE AT THE INDENTATION LINE IN THE WIRE. THE SURGEON DECIDED NOT TO CONTINUE WITH THE USE OF THAT SELECTION. PRODUCT WAS DISCARDED THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. FURTHER INFORMATION RECEIVED ON JANUARY 14TH 2021: THERE WAS NOT AN ADDITIONAL SURGERY REQUIRED TO REMOVE THE FRAGMENT FROM THE PATIENT. THE SURGEON OPTED TO NOT COMPLETE THE PROCEDURE WITH THE REPEATED BREAKAGES. EVENT DESCRIPTION: CHARCOT RECONSTRUCTIVE CASE, PATIENT E.C., (B)(6), MALE 3 - 7.4 G-BEAMS INSERTED 1 WIRE BROKE. WHEN SURGEON WENT TO PLACE IN 5.4MM G-BEAM THE WIRE BROKE OFF IN

  Patient problems: Foreign Body In Patient

  MAUDE report 11284171 ↗
• InjurySep 21, 2020Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: FOOT. SURGERY DESCRIPTION: OTHER. PATIENT INFORMATION: (B)(6) YEAR-OLD, MALE, WEIGHT: OBESE, HEIGHT: NOT AVAILABLE, PREVIOUS HEALTH CONDITION: DIABETIC/STABLE CONDITION. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: DR. (B)(6) WAS ATTEMPTING TO DRIVE THE WIRE THRU THE CALCANEUS INTO THE LATERAL COLUMN. SEVERAL ATTEMPTS WERE MADE TO GET THE CORRECT ANGLE, THEN THE WIRE BROKE AT THE GROOVE ON THE TIP. ANOTHER WIRE WAS OPENED AND BROKE WHEN THE DR. TRIED TO CHANGE THE ANGLE IN THE CALCANEUS. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY: ANOTHER WIRE WAS AVAILABLE BUT DR. (B)(6) CHOOSE NOT TO USE IT AND USE EX FIX TO ACHIEVE. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: APPROXIMATELY 7 MINUTES. AN ADDITIONAL SURGERY WAS NOT REQUIRED

  Patient problems: Foreign Body In Patient

  MAUDE report 10559850 ↗
• InjurySep 21, 2020Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: FOOT. SURGERY DESCRIPTION: OTHER. PATIENT INFORMATION: (B)(6) YEAR-OLD, MALE, WEIGHT: OBESE, HEIGHT: NOT AVAILABLE, PREVIOUS HEALTH CONDITION: DIABETIC/STABLE CONDITION. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: DR. (B)(6) WAS ATTEMPTING TO DRIVE THE WIRE THRU THE CALCANEUS INTO THE LATERAL COLUMN. SEVERAL ATTEMPTS WERE MADE TO GET THE CORRECT ANGLE, THEN THE WIRE BROKE AT THE GROOVE ON THE TIP. ANOTHER WIRE WAS OPENED AND BROKE WHEN THE DR. TRIED TO CHANGE THE ANGLE IN THE CALCANEUS. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY: ANOTHER WIRE WAS AVAILABLE BUT DR. (B)(6) CHOOSE NOT TO USE IT AND USE EX FIX TO ACHIEVE. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: APPROXIMATELY 7 MINUTES. AN ADDITIONAL SURGERY WAS NOT REQUIRED

  Patient problems: Foreign Body In Patient

  MAUDE report 10559849 ↗
• InjurySep 16, 2020Device Dislodged or Dislocated

  BASED ON INFORMATION PROVIDED BY REPRESENTATIVE, TWO GUIDEWIRE TIP DISLOCATED FROM THE GUIDEWIRE AND REMAIN IN THE CALCANEUS OF THE LATERAL COLUMN OF THE PATIENT. THE TIPS DISLOCATED AS THE SURGEON MADE SEVERAL ATTEMPTS TO OBTAIN THE CORRECT ANGLE FOR THE WIRE.

  Patient problems: Insufficient Information

  MAUDE report 10543979 ↗
• InjuryDec 16, 2019Break

  INFORMATION PROVIDED STATES THAT THE K-WIRE TORQUED AT THE NOTCH CAUSING THE WIRE TO BREAK DURING THE SUBTALAR FUSION. THE SHORTER END UP TO THE NOTCH OF THE GUIDE WIRE IS STILL LOCATED INTERIOR OF THE CALCANEUS IN THE PATIENT. THE PATIENT IS STABLE AND THE REMAINDER OF THE DEVICE WAS DISCARDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9475475 ↗
• MalfunctionApr 8, 2019Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: CHARCOT FOOT. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: (B)(6), FEMALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: PER REP (B)(6), THE (B)(4), LOT NUMBER B1235539. DURING A CASE ON (B)(6) 2019, THE PART SNAPPED DURING IMPLANTATION. REP STATES THAT CASE WAS DELAYED FOR ABOUT 5 MINUTES. THE TIP WAS NOT EXPLANTED. CHARCOT FOOT SURGERY. THE HARDWARE WAS RETAINED AND THE BROKEN SHAFT WAS DISCARDED SO NOTHING WILL BE SHIPPED BACK. THE CONDITION OF THE PATIENT WAS UNCHANGED / NOT A FACTOR. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE OF THE SURGICAL TIME. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE O

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8490550 ↗