MAUDE Adverse Event Report: Medos International SÃ rl CH SYMPHONY; Orthosis, Cervical Pedicle Screw Spinal Fixation

Catalog Number	102000000S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction

• Brand Name: SYMPHONY
• Common Device Name: Orthosis, Cervical Pedicle Screw Spinal Fixation
• Manufacturer (Section D): Medos International SÃ rl CH; 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: 50308237
• Report Number: 1526439-2026-01267
• Device Sequence Number: 21490154
• Product Code: NKG
• UDI-Device Identifier: 10705034526799
• UDI-Public: (01)10705034526799
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K190895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• 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: 102000000S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/23/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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