MAUDE Adverse Event Report: Skeletal Dynamics Inc. Skeletal Dynamics; IJS-E Base Plate Assembly

Catalog Number	IJS-ELB-BPA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An implanted ijs-e (internal joint stabilizer - elbow) uncoupled at the arm joint (the proximal locking screw backed out) two months following initial implantation, requiring removal surgery.
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." "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." "for safe effective use of the implant, the surgeon must be thoroughly familiar with the surgical technique, implant, and associated instruments.Improper insertion of the device during implantation may also increase the possibility of loosening, migration and failure of the device or the treatment." review of the images from the case found that the axis pin was not positioned properly in accordance with the surgical technique.Additionally, examination of the returned device revealed damage to the connecting rod splines consistent with not fully seating the splines prior to tightening.

• Brand Name: Skeletal Dynamics
• 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 ; +1(305)596-7585
• MDR Report Key: 50091594
• Report Number: 3006742481-2026-00014
• Device Sequence Number: 21290408
• Product Code: OZI
• UDI-Device Identifier: 00841506104904
• UDI-Public: 00841506104904
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K231447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: IJS-ELB-BPA
• Device Lot Number: AN2505078
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 154 LB
• Patient Race: White