MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; GEMINUS HOOK PLATE

Catalog Number	GMN-HP
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Loss of fracture reduction (4901)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instructions for use for the geminus volar distal radius plating system states the following: "the geminus® volar distal radius plating system should only be used by surgeons who have experience with this system." "please refer to the geminus® distal radius plating system's surgical technique guide (mkt-0000500) to review the surgical approach as described by (b)(6), usa." the surgical technique guide includes surgical steps specifically for installation of the optional hook plate extension, including multiple notes and images to aid with the placement of the device.Based on expert clinician review of fluoroscopic images from the case, it appears that the hook plate extension was placed too distally.No device defect was evident from the provided images.
Event or Problem Description
The volar marginal fragment was not adequately reduced during implantation of a geminus hook plate extension, requiring revision surgery.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: GEMINUS HOOK PLATE
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer Contact: baron villalta ; 7300 n kendall drive; suite 800; miami, FL 33156 ; 3055967585
• MDR Report Key: 25236486
• Report Number: 3006742481-2026-00008
• Device Sequence Number: 13321524
• Product Code: HRS
• UDI-Device Identifier: 00841506101514
• UDI-Public: 00841506101514
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K122310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: GMN-HP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White