MAUDE Adverse Event Report: SKELETAL DYNAMICS SKELETAL DYNAMICS; INTERNAL JOINT STABILIZER

Model Number	IJS-E Base Plate Assembly
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As per the ifu, "if the locking screw or the axis pin is not fully tightened, the construct may loosen, shift, and/or disassemble." testing of this product has determined that, if tightened properly, the construct will not disassemble under normal conditions.It appears that this screw was not tightened properly, resulting in the loosened implant.
Event or Problem Description
Dr.(b)(6) performed x-rays about a month post-implantation and found that the connecting screw of the ijs-e implant had backed out and migrated distally under the olecranon.This screw is a component of the implant which secures both connecting rods to each other and is not installed into bone.The surgeon has decided to leave the implant as is and immobilize the patient.

• Brand Name: SKELETAL DYNAMICS
• Common Device Name: INTERNAL JOINT STABILIZER
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n kendall drive; miami FL 33156
• Manufacturer Contact: alejandro ros ; 7300 n kendall drive; miami, FL 33156 ; 3055967585
• MDR Report Key: 15070153
• Report Number: 3006742481-2022-00006
• Device Sequence Number: 5501022
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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
• 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: 07/18/2022
• Initial Report FDA Received Date: 07/20/2022
• 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: Other; Required Intervention
• Patient Sex: Female