MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 PLY SCRW 3.5X12; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	102035112
Medical Device Problem Codes	Break (1069); Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that almost all inner screws from a symphony construction detached from the head of the screw.The first surgery was on (b)(6) 2024 and in post op exam it was verified that construction failed with the loose locking screws.Almost all pedicle screws remained on place.
Additional Manufacturer Narrative
Additional information has been received, the previously reported event under mrn 1526439-2025-00067, 1526439-2025-00069, and 1526439-2025-00070 are no longer considered reportable at this time as there was no failure of the device.No further follow-ups will be sent under mrn 1526439-2025-00067, 1526439-2025-00069, and 1526439-2025-00070.

• Brand Name: 4.0 PLY SCRW 3.5X12
• 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 (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 21158309
• Report Number: 1526439-2025-00070
• Device Sequence Number: 7631066
• Product Code: NKG
• UDI-Device Identifier: 10705034508689
• UDI-Public: (01)10705034508689
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K181949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 102035112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male