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

Model Number	IJS-E Base Plate Assembly
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant is intended to be removed from the patient when "tissue healing has proven sufficient for joint stability".The device had been implanted for over 12 months when the patient complained of pain.Healing typically occurs for this type of procedure after approximately 6 months.
Event or Problem Description
Patient complained of pain twelve months after implantation of the ijs-e implant.Doctor confirmed via x-ray that the implant had disassembled.

• Brand Name: SKELETAL DYNAMICS IJS-E
• 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 north kendall drive; suite 400; miami 33156
• Manufacturer Contact: mario arbesu ; 7300 north kendall drive; suite 400; miami, FL 33156 ; 3055967585
• MDR Report Key: 13457778
• Report Number: 3006742481-2022-00001
• Device Sequence Number: 15692973
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

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: AN2004010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White