SYMPHONY 1020-35-118SRecalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW diameter 4.0 Rod, 3.5X18mm 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
- 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 10705034524399), received between Aug 19, 2025 and Aug 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionAug 19, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT A CERVICAL SPINAL PROCEDURE (POSTERIOR). AFTER DRILLING WITH A 2.4MM DRILL IN THE LATERAL MASS OF C5 LEFT SIDE, A SYMPHONY SCREW 3.5/18MM BROKE OFF DURING INSERTION IN THE LATERAL MASS. THE BROKEN OFF PART WAS STUCK IN THE LATERAL MASS. IT WAS TAKEN OUT OF THE BONE IN TWO STEPS WITH A TOOL. TWO STEPS WERE NECESSARY BECAUSE THE BROKEN TIP BROKE ONCE MORE DURING EXTRACTION. AFTER ALL OF THE SCREW TIP WAS TAKEN OUT, THE HOLE WAS TAPPED WITH A 3.5 TAP AND THEN A 3.5MM/16MM SCREW WAS INSERTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIFTEEN MINUTE DELAY. THERE IS CONCERN THAT FIXATION MAY NOT HAVE BEEN OPTIMAL. PATIENT WAS OKAY FOLLOWING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22844275 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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