NEOFUSE ANKLE FUSION PLATE
Report
- Report Number
- 3010470577-2025-02211
- Event Type
- Injury
- Date Received
- July 15, 2025
- Date of Event
- April 1, 2022
- Report Date
- July 15, 2025
- Manufacturer
- IN2BONES SAS
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE BATCH NUMBER IS UNKNOWN. THE DEVICE WAS NOT AVAILABLE AND NO PICTURE WAS SHARED. AS NO FURTHER INFORMATION IS AVAILABLE, NO INVESTIGATION ABOUT THE DESIGN OF THE DEVICE CAN BE PERFORMED. HOWEVER, IT CAN BE SUPPOSED THAT THE IMPLANTATION AND EXPLANTATION SURGERIES WERE SUCCESSFUL. ONLY THE PATIENT FEELING ABOUT THE DISCOMFORT WAS COMMUNICATED ALSO, THE DESIGN OF THE DEVICE IS NOT QUESTIONED. NO INFORMATION WAS PROVIDED ABOUT THE CIRCUMSTANCES OF THE EVENT. IN THE IFU022 REVISION 03 OF (B)(6) 2022 FOR NEOFUSE ANKLE FUSION PLATING SYSTEM, IN THE PARAGRAPH 5, COMPLICATIONS, IT IS WRITTEN: "COMPLICATIONS MAY INCLUDE BUT ARE NOT LIMITED TO: PAIN, DISCOMFORT OR ABNORMAL SENSATIONS DUE TO PRESENCE OF THE IMPLANT; ALSO, THE DISCOMFORT FEELING OF THE PATIENT IS A KNOWN COMPLICATIONS. TO CONCLUDE, INVESTIGATION OF THIS EVENT SHOWS THAT: BATCH RECORD CANNOT BE REVIEWED THE DEVICE IS NOT AVAILABLE AND NO PICTURE WAS SHARED DISCOMFORT FEELING IS MENTIONED IN THE IFU NO MORE INFORMATION WAS PROVIDED. THE ROOT CAUSE CANNOT BEEN DETERMINED.
NEOFUSE: THE NEOFUSE PLATING SYSTEM IS A UNIQUE PLATING SYSTEM FOR ANKLE FUSION PROVIDING A HIGH STABILITY AND RIGID FIXATION. THE SYSTEM IS COMPOSED OF AN ANATOMICALLY CONTOURED PLATE, WITH A DISTAL PART ADAPTED TO THE TALAR NECK, AND A PROXIMAL PART ADAPTED TO THE DISTAL TIBIAL EPIPHYSIS AND DIAPHYSIS. THE MOST PROXIMAL TIBIAL HOLE IS AN OBLONG HOLE, WHICH FACILITATES PEROPERATIVE HANDLING OF THE PLATE BY THE SURGEON AS IT ENABLES ITS TEMPORARY FIXATION TO THE BONE. EVENT DESCRIPTION: INFORMATION WAS RECEIVED IN APRIL 2022 (VISIT AT 12 MONTHS POST OP) THAT MATERIAL WAS EXPLANTED 18 MONTHS AFTER IMPLANTATION DUE TO DISCOMFORT.
NEOFUSE: THE NEOFUSE PLATING SYSTEM IS A UNIQUE PLATING SYSTEM FOR ANKLE FUSION PROVIDING A HIGH STABILITY AND RIGID FIXATION. THE SYSTEM IS COMPOSED OF AN ANATOMICALLY CONTOURED PLATE, WITH A DISTAL PART ADAPTED TO THE TALAR NECK, AND A PROXIMAL PART ADAPTED TO THE DISTAL TIBIAL EPIPHYSIS AND DIAPHYSIS. THE MOST PROXIMAL TIBIAL HOLE IS AN OBLONG HOLE, WHICH FACILITATES PEROPERATIVE HANDLING OF THE PLATE BY THE SURGEON AS IT ENABLES ITS TEMPORARY FIXATION TO THE BONE. THE IN2BONES NEOFUSE® ARTHRODESIS PLATING SYSTEM IMPLANTS ARE INTENDED TO BE USED FOR ANTERIOR FIXATION OF THE ANKLE ARTHRODESIS AND FRACTURES, INCLUDING THE DISTAL TIBIA, TALUS AND CALCANEUS. EVENT DESCRIPTION: INFORMATION WAS RECEIVED IN APRIL 2022 (VISIT AT 12 MONTHS POST OP) THAT MATERIAL WAS EXPLANTED 18 MONTHS AFTER IMPLANTATION DUE TO DISCOMFORT: "PMCF NEOFUSE (AJU), IT WAS REPORTED AN ADVERSE EVENT WHICH HAS LED TO A REVISION SURGERY." THIS EVENT WAS ONLY SEEN ON 20-FEB-2025 AS PART OF A PMCF PROSPECTIVE STUDY DATE REVIEW FOR THE NEOFUSE PRODUCT. ADDITIONAL INFORMATION RECEIVED BY (B)(6) (CONMED) ON 26-MAR-2025: "AS PREVIOUSLY MENTIONED, THIS SURGEON HAS MEDICAL ISSUES AND IS NO LONGER RESPONDING TO ANY MARKETING CALLS/MESSAGES, SO IT'S UNLIKELY WE'LL BE ABLE TO GET ANY MORE INFORMATION. 2502-18: I DON'T HAVE THE EVENT DATE AS THIS WAS ADDED BY THE SURGEON IN THE COMMENT SECTION. NOTE THAT WITHIN THE STUDY WE COLLECT CLINICAL OUTCOMES UNTIL 12 MONTHS POST-OP AND THE REVISION OCCURED 18 MONTHS AFTER THE SURGERY (SURGERY DATE: (B)(6) 2020)"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 137737 | NEOFUSE ANKLE FUSION PLATE | NEOFUSE | HRS | IN2BONES SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Female | Required Intervention |