MAUDE Adverse Event Report: Medos International SÃ rl INTRAFIX; Fastener, fixation, biodegradable, soft tissue

Catalog Number	254808
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction

• Brand Name: INTRAFIX
• Common Device Name: Fastener, fixation, biodegradable, soft tissue
• Manufacturer (Section D): Medos International SÃ rl; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): Medos International SÃ rl; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50131915
• Report Number: 1221934-2026-03455
• Device Sequence Number: 13390306
• Product Code: MAI
• UDI-Device Identifier: 10886705026753
• UDI-Public: (01)10886705026753(10)107SKX(17)280331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup

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: 254808
• Device Lot Number: 107SKX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/01/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Supplement Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• 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
• Patient Sex: Unknown