SYMPHONY 1020-50-428SRecalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM CORTICAL FIX POLYAXIAL SCREW REDUCTION CANNULATED Diameter 4.0 Rod, 5.0X28mm 3.5 4.0 · Class 2 · Implant
All models of SYMPHONY (113)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034525143), received between Jan 27, 2026 and Jan 27, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Compatibility Problem” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Compatibility Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Compatibility Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A POSTERIOR CERVICAL DECOMPRESSION AND FUSION(TH1) FOR OPLL ON (B)(6) 2026. DURING THE SURGERY, WITH THE NAVIGATION DRIVER, NAVIGATION SLEEVE, AND SRI HEAD HOLDING SLEEVE ASSEMBLED, IT WAS DIFFICULT TO INSERT THE SCREW STRAIGHT. INSERTION UNDER THE NAVIGATION SYSTEM WAS ABANDONED AND A STANDARD SCREWDRIVER WAS USED. AFTER CONFIRMING THE MISALIGNMENT WITH AN O-ARM, THE SCREW WAS REINSERTED. [OCCURRENCE] THE INSERTION METHOD AND SIZE WERE CONFIRMED PREOPERATIVELY, AND THE SCREW WAS SELECTED FOR TH1. AFTER DEPLOYMENT, THE NAVIGATION ANTENNA WAS INSTALLED AND AN O-ARM IMAGE WAS TAKEN. AFTER CREATING THE SCREW PATH WITH TH1, THE SCREW WAS ATTACHED TO THE NAVIGATION DRIVER, BUT DUE TO POOR FIT, IT TOOK TIME, AND INSERTION UNDER THE NAVIGATION SYSTEM WAS ABANDONED. AFTER INSERTING WITH A STANDARD SCREWDRIVER, THE SCREW WAS REINSERTED AFTER CONFIRMING THE MISALIGNMENT WITH AN O-ARM. THE TAB ON THE LEFT SIDE DID NOT BREAK, BUT THE STANDARD SCREW WAS UNSEALED AND REINSERTED. [RESPONSE] THE RIGHT-SIDE REDUCTION SCREW WAS REINSERTED UNDER THE NAVIGATION SYSTEM AFTER BREAKING THE TAB. THE TAB ON THE LEFT SIDE DID NOT BREAK, SO A STANDARD SCREW WAS USED AND
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189612 ↗
Other Posterior cervical screw system devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2002Orthofix 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
- 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
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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