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	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use for the ijs-e system includes the following warning: "the device is not designed to withstand the stress of weight bearing, load bearing, or excessive physical activity.Device loosening or breakage may occur when the implant is subjected to excessive loading during soft tissue healing or delayed healing." the patient's use of their splinted arm while confined to a wheelchair likely contributed to this failure.
Event or Problem Description
An implanted ijs-e (internal joint stabilizer - elbow) broke at the base of the boom arm six days 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: 18365232
• Report Number: 3006742481-2023-00019
• Device Sequence Number: 8109110
• Product Code: OZI
• UDI-Device Identifier: 00841506104904
• UDI-Public: 00841506104904
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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 Catalogue Number: IJS-ELB-BPA
• Device Lot Number: AN2201007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2022
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White