SYMPHONY 1020-35-130SRecalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW diameter 4.0 Rod, 3.5X30mm 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034524450), received between Nov 29, 2021 and Dec 12, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Difficult to Open or Remove Packaging Material1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2025Break; Break
IT WAS REPORTED THAT THERE WAS A POSTOPERATIVE FRACTURE OF THE SYMPHONY SCREWS, WHICH HAD BEEN IMPLANTED IN (B)(6) 2025. THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2025 DUE TO IMPLANT FRACTURE. THE PATIENT DID NOT REPORT A FALL.
Patient problems: Insufficient Information
MAUDE report 23794577 ↗InjuryDec 12, 2025Break; Break
IT WAS REPORTED THAT THERE WAS A POSTOPERATIVE FRACTURE OF THE SYMPHONY SCREWS, WHICH HAD BEEN IMPLANTED IN (B)(6) 2025. THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2025 DUE TO IMPLANT FRACTURE. THE PATIENT DID NOT REPORT A FALL.
Patient problems: Insufficient Information
MAUDE report 23794572 ↗MalfunctionNov 29, 2021Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE REMOVAL OF THE SCREW FROM THE TUBE THE SCREW SCRAPED ON THE PLASTIC TUBE AND CREATED PLASTIC SHAVINGS. THE PLASTIC SHAVINGS WERE REMOVED AND THE SCREW WAS IMPLANTED. THE TUBE WILL BE RETURNED FOR INVESTIGATION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THREE(3) MINUTES SURGICAL DELAY. NO ADVERSE PATIENT HARM. THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 3.5X30. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12883992 ↗
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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