SYMPHONY 1020-40-114Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW diameter 4.0 Rod, 4.0X14mm · Class 2 · Implant
All models of SYMPHONY (113)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034512242), received between Sep 23, 2020 and Apr 17, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- Injury1
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2024Break; Break
PATIENT OUTCOME IS REPORTED AS FINE.
Patient problems: Insufficient Information
MAUDE report 19123761 ↗InjurySep 23, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020, WHILE PLACING THE C7 SCREW, THE SURGEON TAPPED WITH A 4.0 TAP AND AS HE WAS DOING THE FINAL TURN ON THE 4.0X14 SCREW THE SCREW SHEARED OFF BELOW THE POLY HEAD. THE SHANK WAS RECOVERED AND THEY SKIPPED THAT LEVEL. PATIENT HAD GIANT CELL NEOPLASM WITH A SOLID ANEURYSMAL BONE CYST. HE WAS TREATED WITH DENOSUMAB WHICH MAKES THE CYST HARD. THE BONE WAS EXTREMELY HARD AT THIS LEVEL. POSTERIOR CERVICAL C6-T2. THE SCREW SHANK WAS DRILLED OUT AND RECOVERED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN (10) MINUTE SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); DRILL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 4.0X14. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Injury; No Code Available
MAUDE report 10575044 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page