SYMPHONY 1020-35-114Recalls & reported problems

Medos International Sàrl · SYMPHONY OCT SYSTEM POLYAXIAL SCREW Diameter 4.0 Rod, 3.5X14mm · Class 2 · Implant

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 10705034508696), received between Jan 26, 2026 and Jan 26, 2026 — 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1
Entrapment of Device1

Patient problems

Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 26, 2026Break; Entrapment of Device
IT WAS REPORTED THAT SURGEON WAS PLACING A SCREW INTO THE CERVICAL SPINE, WHEN THE HEAD OF THE SCREW BROKE OFF. SURGEON TRIED TO REMOVE THE SHAFT OF THE SCREW FROM WITHIN THE PATIENT, BUT DECIDED TO LEAVE IT IN SINCE IT WAS DIFFICULT TO GET OUT. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES.
Patient problems: Foreign Body In Patient
MAUDE report 24177750 ↗

Device details

UDI-DI	`10705034508696`
Brand	SYMPHONY
Model	1020-35-114
Catalog no.	102035114
Company	Medos International Sàrl
Product code	KWP · APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Class	Class 2
FDA submission	K181949, K190895
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Sep 11, 2024

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.