MAUDE Adverse Event Report: IN2BONES SAS IBS¿; IBS 2.5-C COMPRESSION SCREW, DIAM2.5 LG 28MM T7

Model Number	S25 ST028
Medical Device Problem Codes	Use of Device Problem (1670); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
At the time of manually inserting the screw and visualizing with x-rays, it was detected that the screw was bent.Therefore, it was removed and this defect was confirmed.It was replaced with another screw of the same size.
Additional Manufacturer Narrative
N/a.

• Brand Name: IBS¿
• Common Device Name: IBS 2.5-C COMPRESSION SCREW, DIAM2.5 LG 28MM T7
• Manufacturer (Section D): IN2BONES SAS; 97 allée alexandre borodine; immeuble sequoia 3; saint-priest, 69800 ; FR 69800
• Manufacturer (Section G): IN2BONES SAS; 97 allée alexandre borodine; immeuble sequoia 3; saint-priest, 69800 ; FR 69800
• Manufacturer Contact: benjamin krempel ; 97 allée alexandre borodine; immeuble sequoia 3; saint-priest, 69800 ; FR 69800
• MDR Report Key: 25012667
• Report Number: 3010470577-2026-04041
• Device Sequence Number: 10295572
• Product Code: HWC
• UDI-Device Identifier: 03760225710173
• UDI-Public: 03760225710173
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K131920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: S25 ST028
• Device Catalogue Number: S25 ST028
• Device Lot Number: 2301145
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 06/30/2026
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female