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

Catalog Number	IJS-ELB-BPA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use for the ijs-e system include contraindications advising against use on patients with "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".No visuals were provided, however the surgeon did describe the patient as having experienced a terrible triad injury which also involved implantation of a coronoid plate.This patient may not have been suitable for implantation of this device given the ijs-e system's contraindications for patients with significant bone loss and/or additional load being applied onto the ijs-e construct as a result of their weakened coronoid bone.
Event or Problem Description
An implanted ijs-e (internal joint stabilizer - elbow) uncoupled at the arm joint (the proximal locking screw backed out) in the weeks following surgery.

• 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 (Section G): 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: 19240048
• Report Number: 3006742481-2024-00008
• Device Sequence Number: 7495016
• Product Code: OZI
• UDI-Device Identifier: 00841506104904
• UDI-Public: 00841506104904
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IJS-ELB-BPA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White