MAUDE Adverse Event Report: Medos International SÃ rl CH EXPEDIUM VERSE; Appliance, fixation, spinal intervertebral body

Catalog Number	199723530S
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction

• Brand Name: EXPEDIUM VERSE
• Common Device Name: Appliance, fixation, spinal intervertebral body
• Manufacturer (Section D): Medos International SÃ rl CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): Medos Int Spine; 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: 50898824
• Report Number: 1526439-2026-01489
• Device Sequence Number: 20290980
• Product Code: KWQ
• UDI-Device Identifier: 10705034443294
• UDI-Public: (01)10705034443294(17)300228(10)425639
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 199723530S
• Device Lot Number: 425639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2025
• 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 Age: 73 YR
• Patient Sex: Female