MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; SMOOTH PEG, LOCKING, 2.00MM X 18MM, TI

Catalog Number	SPLS-20180-TS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use for the geminus® distal radius plating system includes the following warnings: "all screws must be implanted and fully tightened into the plate to maintain the integrity and strength of thefinished construct.If the screws are not attached and/or fully tightened, a non-union, delayed union or construct failure may occur." "the use of power tools for the installation of the screws and pegs is not recommended and may lead to cross threading and damage to the screws and/or plates." although the devices have not been made available for analysis at this time, likely causes of failure include not fully tightening the screws or deviating from the recommended surgical technique.
Event or Problem Description
Two smooth peg locking screws backed out of a patient's geminus plate within one month of implantation, requiring revision surgery.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: SMOOTH PEG, LOCKING, 2.00MM X 18MM, TI
• 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: 22486265
• Report Number: 3006742481-2025-00006
• Device Sequence Number: 8544710
• Product Code: HRS
• UDI-Device Identifier: 00841506102993
• UDI-Public: 00841506102993
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111620
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: SPLS-20180-TS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White