MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS, INC.; DOUBLE IJS-E, ASSEMBLY

Catalog Number	IJS-DBL-BPA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use for the ijs-e system states the following: "the ijs-e system should not be used if the following are present: active or latent infection, insufficient quantity or quality of bone (bone loss greater than 30% of the total articulation or involving an entire column of the distal humerus, coronoid bone loss of 50% or more) and/or soft tissue, material sensitivity, or patients who are unwilling or incapable of following post operative care instructions." "improper placement, positioning, alignment or fixation of the ijs-e construct may result in unusual stress conditions which may lead to subsequent reduction in the service life of the components, construct failure, postoperative complications or ineffective treatment." "the device is not designed to withstand the stress of weight bearing, load bearing, or excessive physical activity.Device loosening or breakage may occur when the implant is subjected to excessive loading during soft tissue healing or delayed healing." based on the information currently available, and because the device was not returned for evaluation, a definitive root cause could not be established at this time, however potential contributing factors include patient anatomy, construct positioning, and loading conditions.
Event or Problem Description
An implanted double ijs-e (internal joint stabilizer - elbow) broke at the base of both booms, requiring revision/removal surgery.

• Brand Name: SKELETAL DYNAMICS, INC.
• Common Device Name: DOUBLE IJS-E, ASSEMBLY
• 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: 25225469
• Report Number: 3006742481-2026-00007
• Device Sequence Number: 15952876
• Product Code: OZI
• UDI-Device Identifier: 00841506109138
• UDI-Public: 00841506109138
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K231447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 05/19/2026

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: Lay User/Patient
• Device Catalogue Number: IJS-DBL-BPA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2026
• Initial Report FDA Received Date: 05/19/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Ethnicity: Hispanic
• Patient Race: White