MAUDE Adverse Event Report: BONEBRIDGE SALGINA 2.5MM DISTAL RADIUS SYSTEM; SALGINA 2.5MM VOLAR DISTAL RADIUS PLATE, NARROW, LEFT

Model Number	B-111000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A distal radius fracture treated with the bonebridge salgina device in solothurn, switzerland, resulted in implant failure six weeks postoperatively due to extensive screw dislocation.The patient is a 67-year-old woman without a diagnosed osteoporosis, however exhibiting poor bone quality, which contributed to the failure.Additionally, patient non-compliance was identified as a factor.Details from the surgical report provided by the operating surgeon: the patient sustained a displaced multifragmentary intra-articular fracture of the left radius on (b)(6) 2024.Open reduction and palmar plate osteosynthesis of the distal left radius was performed on (b)(6) 2025, using the salgina.During the procedure, the bone was observed to be very soft; however, intraoperative imaging confirmed proper fracture reduction and correct implant positioning.Postoperatively, the wrist was immobilized with a splint, which was later replaced with a forearm cast for six weeks.Weight-bearing and resistance exercises were restricted during this period.The six-week postoperative follow-up on (b)(6) 2025, revealed screw loosening and full fracture displacement, accompanied by a dorsal tilt of approximately 20° and an ulna-plus deformity.The patient reported minimal pain but admitted to occasional unintended loading of the hand, such as supporting herself while getting up and using the railing when climbing stairs.There were no wound complications, and sensitivity and motor function remained intact.The surgeon concluded that the distal radius had completely dislocated, primarily due to the patient's poor bone quality.The surgeon stated that in retrospect, a temporary wrist-spanning arthrodesis would have been advisable.However, since intraoperative positioning was correct and the screws initially provided adequate fixation, this step was not taken.Despite cast immobilization, complete dislocation occurred, influenced by the patient's mal-compliance.The wrist was re-immobilized.Revision surgery is planned.

• Brand Name: SALGINA 2.5MM DISTAL RADIUS SYSTEM
• Common Device Name: SALGINA 2.5MM VOLAR DISTAL RADIUS PLATE, NARROW, LEFT
• Manufacturer (Section D): BONEBRIDGE; bahnhofstrasse 11; zug, 6300 ; SZ 6300
• Manufacturer (Section G): BONEBRIDGE; bahnhofstrasse 11; zug, 6300 ; SZ 6300
• Manufacturer Contact: michelle gumpelmayer ; bahnhofstrasse 11; zug, 6300 ; SZ 6300
• MDR Report Key: 21635488
• Report Number: 3021010222-2025-00001
• Device Sequence Number: 9372165
• Product Code: HRS
• UDI-Device Identifier: 07640187460018
• UDI-Public: 07640187460018
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K243308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: B-111000
• Device Lot Number: 300228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female