MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; 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 loss 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.The ijs-elbow system is not intended to be a load-bearing implant.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 not an indication for the ijs-elbow system.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
Distal connecting rod of ijs-e stabilizer broke 6 months post-op.Patient is a female 5'4 220 lbs.

• Brand Name: SKELETAL DYNAMICS INC.
• 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: 15747172
• Report Number: 3006742481-2022-00010
• Device Sequence Number: 20616392
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IJS-E Base Plate Assembly
• Device Catalogue Number: IJS-ELB-BPA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2022
• 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
• Patient Weight: 100 KG