MAUDE Adverse Event Report: FOUNDATION FUSION SOLUTIONS, LLC TRANSLOC 3D; SI JOINT FUSION

Catalog Number	TS85-45
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Five attempt were made to gather data from the operative physician, and 5 attempts were made to speak to facility personell.The physician's operative notes were finally released to manufacturer through the physician's attorney.The physician's operative note reflected the presence of poor bone quality as a likely reason for the malpostion of the implant.The physician's office indicated that at the patient's 2 week follow-up, the patient had no complaints of pain or complaints relating to the malpositioned device.No other info available.
Event or Problem Description
Si joint fusion implant (screw) was malpositioned upon implantation.Attempts to back up the implant to a more ideal depth increased the malpostion.The bone was noted by the operative physician to be "quite soft." attempts to retrieve the implant with a clamp resulted in the implant advancing into the presacral space.Patient procedure was concluded, and the operative incision was closed.The patient was transported to the er for evaluation by a vascular surgeon where a cta scan was performed.Patient remained stable throughout.Patient was released from the er without intervention or removal of the implant.

• Brand Name: TRANSLOC 3D
• Common Device Name: SI JOINT FUSION
• Manufacturer (Section D): FOUNDATION FUSION SOLUTIONS, LLC; 11916 s oxford avenue; suite 206; tulsa OK 74137
• Manufacturer Contact: robert compton ; 11916 s. oxford avenue; suite 206; tulsa, OK 74137 ; 4173099459
• MDR Report Key: 19305593
• Report Number: 3013912820-2024-00001
• Device Sequence Number: 7332975
• Product Code: OUR
• UDI-Device Identifier: 00850026642070
• UDI-Public: 00850026642070
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: TS85-45
• Device Lot Number: PFW20230906-02D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• 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
• Patient Age: 82 YR
• Patient Sex: Male