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	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Installation-Related Problem (2965)
Health Effect - Clinical Codes	Failure of Implant (1924); Laceration(s) (1946); Joint Laxity (4526)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As per report, this surgeon was a first-time user of the ijs-e system.Based on review of x-rays provided, the images indicate that the axis pin was not fully inserted and other errors occurred during installation.Patient was hard-casted and the implant was found exposed during follow-up visit.It appears that errors involving the position and orientation of the implant assembly most likely contributed to this failure.The device was not available for return.
Event or Problem Description
Ijs-e implant disassembled about 2 weeks post-op.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: IJS-E BASE PLATE ASSEMBLY
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; miami FL 33156
• Manufacturer Contact: alejandro ros ; 7300 n kendall drive; miami, FL 33156 ; 3055967585
• MDR Report Key: 16254875
• Report Number: 3006742481-2023-00003
• Device Sequence Number: 14789998
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/24/2023

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 01/27/2023
• 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
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White