MAUDE Adverse Event Report: DIXI Medical Guiding Screw / Anchor Bolt; ACS-030SMS-10

Catalog Number	ACS-030SMS-10
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury

• Brand Name: Guiding Screw / Anchor Bolt
• Common Device Name: ACS-030SMS-10
• Manufacturer (Section D): DIXI Medical; 2a route de; pouligney-chaudefontaine; marchaux-chaudefontaine, doubs 25640 ; FR 25640
• Manufacturer (Section G): DIXI Medical; 2a route de; pouligney-chaudefontaine; marchaux-chaudefontaine, doubs 25640 ; FR 25640
• Manufacturer Contact: quentin rieth ; 2a route de pouligney-chaudefontaine; marchaux-chaudefontaine, doubs 25640 ; FR 25640
• MDR Report Key: 50928065
• Report Number: 3007636029-2026-00004
• Device Sequence Number: 10734716
• Product Code: GZL
• UDI-Device Identifier: 03664539000688
• UDI-Public: 03664539000688
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K170959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Catalogue Number: ACS-030SMS-10
• Device Lot Number: 220058
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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: Hospitalization
• Patient Sex: Unknown