MAUDE Adverse Event Report: GETSET SURGICAL S.A. : GOPLF! POSTERIOR LATERAL FUSION SYSTEM; SET SCREW

Model Number	3100010
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Damaged Thread (4075)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mdr reporting follow-up activities from capa-10 due to late filing in the usa.
Event or Problem Description
The locking screw was misaligned with the threads of the pedical screw head , which did not allow the screw threads to be properly joined to the pedical screw head threads, and thus was unable to ensure that the rod was properly secured in the pedical screw head.

• Brand Name: : GOPLF! POSTERIOR LATERAL FUSION SYSTEM
• Common Device Name: SET SCREW
• Manufacturer (Section D): GETSET SURGICAL S.A.; route de la corniche 4; epalinges vaud, 1066 ; WZ 1066
• Manufacturer (Section G): LISI MEDICAL FASTENERS; 19 chemin de la traille; neyron bp100, miribel 01701 ; FR 01701
• Manufacturer Contact: jowiita sokalska ; route de la corniche 4; epalinges vaud, 1066 ; WZ 1066
• MDR Report Key: 22630920
• Report Number: 3017780544-2025-00001
• Device Sequence Number: 13030193
• Product Code: NKB
• UDI-Device Identifier: 07640387660140
• UDI-Public: 07640387660140
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K202505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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 Expiration Date: 08/31/2026
• Device Model Number: 3100010
• Device Catalogue Number: 3100010
• Device Lot Number: LIE077154 / SEE24334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• 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 Sex: Unknown