MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; IJS-E BASE PLATE ASSEMBLY

Catalog Number	IJS-ELB-BPA
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use for the ijs-e system states the following: "the locking screws of the construct and the axis pin must be installed and fully tightened to ensure that the construct will maintain the positioning and angles established intraoperatively.If the locking screws or the axis pin are not attached and/or fully tightened, the construct may loosen, shift and/or become disassembled subcutaneously." "the ijs-e construct connecting rod splines must be fully seated prior to tightening.Improper positioning may result in loosening of the construct." "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." "potential ijs-e construct failures such as implant breakage, loosening, instability, delayed soft tissue healing, soft tissue irritation, or incomplete healing may occur as a result of non-compliance to postoperative rehabilitation, excessive elbow activities or construct overloading." "the patient must be cautioned about the use, limitations and possible adverse effects of this device including the possibility of device or treatment failure as a result loosening, stress, excessive activity, or weight bearing or load bearing, and the possibility of nerve or soft tissue damage related to either surgical trauma or the presence of the device." the patient was under the impression that the ijs-e construct was much stronger than is indicated.The patient may have stressed the device by engaging in excessive physical activities like swimming prior to when sufficient healing could take place.
Event or Problem Description
A patient experienced repeated issues with implanted ijs-e (internal joint stabilizer - elbow) constructs within 2-3 weeks of initial implantation, including breakage of the distal connecting rod and uncoupling at the arm joint (the proximal locking screw backed out).

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: IJS-E BASE PLATE 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: 23631012
• Report Number: 3006742481-2025-00010
• Device Sequence Number: 9317357
• Product Code: OZI
• UDI-Device Identifier: 00841506104904
• UDI-Public: 00841506104904
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K153208
• 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: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: IJS-ELB-BPA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/24/2025
• 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: 20 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Hispanic
• Patient Race: White