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

Catalog Number	IJS-ELB-BPA
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An implanted ijs-e (internal joint stabilizer: elbow) failed at the base plate rod four months after initial implantation.
Additional Manufacturer Narrative
The instructions for use for the ijs-e system includes the following potentially relevant warnings and precautions: "the ijs-e construct is intended to be explanted when tissue healing has proven sufficient for joint stability.Failure to remove the implant after tissue healing increases likelihood of the device to bend, break, disassemble, cause localized tissue reactions, pain, or discomfort." "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." "potential ijs-e construct failures such as stress failures of the bones, loosening of the construct, instability, delayed soft tissue healing, soft tissue irritation, or incomplete healing may occur as a result of non-compliance to post-operative rehabilitation, excessive elbow activities, or construct overloading." "the benefits from implant surgery may not meet the patient's expectations or may deteriorate over time, requiring revision surgery to replace the implant or to carry out alternative procedures." "the ijs-e system has not been evaluated in patients with instability secondary to surgical release of soft tissue." although it cannot be confirmed at this time with the limited information available, the ijs-e construct may have been improperly stressed, resulting in failure that prompted removal after four months.

• 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: 20487182
• Report Number: 3006742481-2024-00013
• Device Sequence Number: 11814228
• 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
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: IJS-ELB-BPA
• Device Lot Number: AN2201006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2022
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic
• Patient Race: White