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	Off-Label Use (1494); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An implanted ijs-e (internal joint stabilizer - elbow) uncoupled at the arm junction in the weeks following surgery.This patient has a history of surgical complications.
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".The complainant described the patient as having previously undergone "many operations and has compromised anatomy", a statement which is supported by fluoroscopic images showcasing significant bone loss.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.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: IJS-E BASE PLATE ASSEMBLY
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 400; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 400; miami FL 33156
• Manufacturer Contact: baron villalta ; 7300 n kendall drive; suite 400; miami, FL 33156
• MDR Report Key: 17090373
• Report Number: 3006742481-2023-00012
• Device Sequence Number: 2723416
• Product Code: OZI
• UDI-Device Identifier: 00841506104904
• UDI-Public: 00841506104904
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 06/02/2023

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
• Operator of Device: Health Professional
• Device Model Number: IJS-E Base Plate Assembly
• Device Catalogue Number: IJS-ELB-BPA
• Device Lot Number: AN2205006
• 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: 06/08/2023
• 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: Female