MAUDE Adverse Event Report: NOVATEP SAS - RENNES - FRANCE NEXIS; COMPRESSIVE SCREW Ø2.9 LG32

Model Number	SC020032
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the first implantation, the fragment was detected on xrays imaging and was intentionally left in side.After its subsequent removal of the fragment, no corrective procedure was undertaken to reposition the screw.
Event or Problem Description
Initial information: ansm (french competent authority) report from the user indicating a broken screw.Additional information on august 6th: during implantation in february, slight metal filings came loose from the distal thread of the screw.This part remained in the soft tissue surrounding the bone.Four months later, as the patient experienced pain and discomfort, x-rays were performed, showing that the fragment had migrated in the soft tissue.The surgeon decided to re-open the patient so as to remove the thread.This correction surgery was performed on (b)(6), 2025.The xrays show a deep insertion of the screw, so much that it seems to protrude at least 3mm from the bone.Nb: incident reported to ansm by the user.Ref # (b)(4).A second report has been addressed to ansm by the user: # (b)(6).It mentions the second screw used at the same time but it turned out to be irrelevant as this second screw wasn't problematic.

• Brand Name: NEXIS
• Common Device Name: COMPRESSIVE SCREW Ø2.9 LG32
• Manufacturer (Section D): NOVATEP SAS - RENNES - FRANCE; 2 all jacques frimot, 35000 re; rennes, 35000 ; FR 35000
• Manufacturer (Section G): NOVASTEP; 2 all jacques frimot, 35000 re; rennes, 35000 ; FR 35000
• Manufacturer Contact: patrick lebas ; 2 all jacques frimot, 35000 rennes; rennes, 35000 ; FR 35000
• MDR Report Key: 22883708
• Report Number: 3010673777-2025-00002
• Device Sequence Number: 9640907
• Product Code: HWC
• UDI-Device Identifier: 03700879501215
• UDI-Public: 03700879501215
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/22/2025

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 Model Number: SC020032
• Device Lot Number: L01805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2025
• 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