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 Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on review of the x-ray images provided, it appears this event was a result of off-label use of the ijs-e.The instructions for use of the device states "improper placement, positioning, alignment or fixation of the construct may result in usual stress conditions which may lead to subsequent reduction in the service life of the components, construct failure, postoperative complications or ineffective treatment.For safe and effective use of the implant, the surgeon must be thoroughly familiar with the surgical technique for the device, 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 treatment." the surgeon appeared to stack two base plates on top of each other, which is contraindicated by the surgical technique guide and instructions for use of the device.
Event or Problem Description
A surgeon implanted two internal elbow joint stabilizers stacked on top of each other and both axis pins loosened.

• 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: 16850564
• Report Number: 3006742481-2023-00007
• Device Sequence Number: 15094225
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring,Replace
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2023
• 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: Unknown