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

Model Number	IJS-E Base Plate Assembly
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As per the indications for use of the ijs-e system, "the system is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.Potential ijs-e construct failures such as stress fractures of the bones, loosening of the construct, instability, delayed soft tissue healing, or incomplete healing may occur." furthermore, the device's contraindications state " the ijs-e system should not be used if the following are present: active or latent infection, sepsis, insufficient quantity/quality of bone (bone loss greater than 30% of the total articulation or involving an entire column of the distal humerus, coronoid bone losee of 50% or more) and/or soft tissue, material sensitivity, or patients with open growth plates." the implant is intended for temporary stabilization while bone and ligament healing occurs.As per reports, the surgeon installed the implant to "salvage the natural anatomy for a patient who likely needs a total elbow replacement down the road." the x-rays indicate the patient had severe bone deformity and was reported to have rheumatoid arthritis.As per sd's investigation, the available information indicates noncompliance with the ijs-e system's instructions for use.As per reports from the surgeon, prior to implantation they were aware that this case would push the limits of the ijs-e system and possibly would result in ineffective treatment.
Event or Problem Description
Proximal connecting rod of ijs-e stabilizer broke at the clamp.Patient had rheumatoid arthritis and did not heal properly.X-rays were taken 6 months post-op.

• Brand Name: SKELETAL DYNAMICS IJS-E
• Common Device Name: IJS-E BASE PLATE ASSEMBLY
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; miami FL 33156
• Manufacturer Contact: alejandro ros ; 7300 n kendall drive; miami, FL 33156 ; 3055967585
• MDR Report Key: 15748999
• Report Number: 3006742481-2022-00009
• Device Sequence Number: 6225478
• Product Code: OZI
• UDI-Device Identifier: 00841506104904
• UDI-Public: 00841506104904
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Patient Monitoring,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 11/07/2022

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?: No
• Device Model Number: IJS-E Base Plate Assembly
• Device Catalogue Number: IJS-ELB-BPA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2022
• Initial Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female