SYMPHONY 1020-35-110SRecalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW diameter 4.0 Rod, 3.5X10mm 3.5 and 4.0 · Class 2 · Implant
All models of SYMPHONY (113)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034524351), received between Oct 27, 2025 and Oct 27, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
ON (B)(6) 2025, A SITE ASSOCIATE IN THE FIELD SALES NETWORK SITE IDENTIFIED (4) PRODUCTS WITH A DATA BATCH DISCREPANCY. ALL OF THE PARTS ARE IN QUARANTINE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23395143 ↗MalfunctionOct 27, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
ON OCTOBER 7, 2025, A SITE ASSOCIATE IN THE FIELD SALES NETWORK SITE IDENTIFIED (4) PRODUCTS WITH A DATA BATCH DISCREPANCY. ALL OF THE PARTS ARE IN QUARANTINE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23395142 ↗MalfunctionOct 27, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
ON OCTOBER 7, 2025, A SITE ASSOCIATE IN THE FIELD SALES NETWORK SITE IDENTIFIED (4) PRODUCTS WITH A DATA BATCH DISCREPANCY. ALL OF THE PARTS ARE IN QUARANTINE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23395118 ↗MalfunctionOct 27, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
ON OCTOBER 7, 2025, A SITE ASSOCIATE IN THE FIELD SALES NETWORK SITE IDENTIFIED (4) PRODUCTS WITH A DATA BATCH DISCREPANCY. ALL OF THE PARTS ARE IN QUARANTINE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23395115 ↗
Other Posterior cervical screw system devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- YUKON OCT Spinal System 7601-05030VB Spine LLC · Orthosis, cervical pedicle screw spinal fixation15 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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