MAUDE Adverse Event Report: BONEBRIDGE AG SALGINA; SALGINA 2.5MM VOLAR DISTAL RADIUS PLATE, STANDARD, 3 H, LEFT

Model Number	SALGINA 2.5MM VOLAR DISTAL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 16 december, bonebridge received market feedback from (b)(6) switzerland reporting an osteosynthesis material removal (osme) and revision osteosynthesis performed after the 6-week follow-up due to secondary dislocation of the distal locking screws of a salgina distal radius plate.The treating surgeon described the patient as being very active and stated that postoperative non-compliance was a highly likely contributing factor.According to the surgeon early excessive loading of the operated hand, including supporting body weight shortly after surgery, was considered a likely contributing factor.According to the operative report, all distal locking screws were inserted using a torque-limiting device with power assistance and were manually checked and retightened at the end of the procedure.Imaging & clinical findings: postoperative imaging confirmed that all distal screws were positioned extra-articularly.At the 6-week follow-up, ct imaging showed secondary displacement of the distal fragment block, with the screws remaining fixed in bone while the fragment block had subsided relative to the plate.This finding indicates a loss of locking integrity at the screw-plate interface rather than screw pull-out or intra-articular penetration.This indicates that the construct stabilty was not ideal: it was noted that the second distal screw row was not used during the initial fixation, which may have reduced construct stability and increased susceptibility to micromotion and loss of locking under mechanical loading.The surgeon was informed that the second row could have been filled, and she confirmed that this would have been a good possibility.Mechanical assessment based on the information provided the incident is assessed as resulting from insufficient construct stability for the fracture pattern combined with probable biomechanical overload in the early postoperative phase.Early wrist loading in an active patient may have generated forces exceeding the locking capacity at the screw-plate interface, leading to gradual loss of fixation and subsidence of the distal fragment block despite the screws remaining anchored in bone.Conclusion: overall, the event is considered a multifactorial fixation problem influenced by construct configuration, high patient activity level, postoperative non-compliance, and non-use of all available distal locking options.Based on the available information, there is no evidence of device malfunction or product nonconformity, and the incident is not considered product-specific.
Additional Manufacturer Narrative
The incident resulted due to a multifactorial fixation problem influenced by construct configuration, high patient activity level, possible post-operative non-compliance, and non-use of all available distal locking options.Based on the available information, there is no evidence of device malfunction or product nonconformity, and the incident is not considered product-specific.

• Brand Name: SALGINA
• Common Device Name: SALGINA 2.5MM VOLAR DISTAL RADIUS PLATE, STANDARD, 3 H, LEFT
• Manufacturer (Section D): BONEBRIDGE AG; bahnhofstrasse 11; zug, 6300 ; SZ 6300
• Manufacturer Contact: salome brütsch ; bahnhofstrasse 11; zug 6300 ; SZ 6300
• MDR Report Key: 24052100
• Report Number: 3021010222-2026-00001
• Device Sequence Number: 9883566
• Product Code: HRS
• UDI-Device Identifier: 07640187462630
• UDI-Public: 07640187462630
• 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
• Device Explanted 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): 01/09/2026

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: SALGINA 2.5MM VOLAR DISTAL
• Device Catalogue Number: B-111200
• Device Lot Number: UNKOWN
• 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: 01/09/2026
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (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: Other
• Patient Sex: Female