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

Catalog Number	IJS-ELB-BPA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An implanted ijs-e (internal joint stabilizer - elbow) broke at the base of the boom arm four weeks after initial implantation.
Additional Manufacturer Narrative
The instructions for use for the ijs-e system includes the following warning: "the patient should be informed about the importance of following the post-operative rehabilitation prescribed in order to fully understand the possible limitations in activities of daily living." the patient did not follow the post-operative rehabilitation prescribed by the surgeon, stressing the implant by working in the fields of their farm only three weeks after initial implantation.

• 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: 19092955
• Report Number: 3006742481-2024-00005
• Device Sequence Number: 7558690
• Product Code: OZI
• UDI-Device Identifier: 00841506104904
• UDI-Public: 00841506104904
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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?: No
• Device Catalogue Number: IJS-ELB-BPA
• Device Lot Number: AN2304007
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White