SYMPHONY 1020-19-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034518886), received between May 20, 2021 and Jun 19, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A TRAUMATIC BRAIN INJURY AFTER A MOTOR VEHICLE ACCIDENT IN (B)(6) 2020. SHE EXPERIENCED MULTIPLE INJURIES INCLUDING VERTEBRAL FRACTURES WHICH RESULTED IN SPINAL FUSION SURGERY FORM C1-S1. ORIGINAL SURGERY WAS PERFORMED IN (B)(6) 2020 AND DID NOT INCLUDE SYNTHES DEVICES. SURGERY RESULTED IN LIMITED RANGE OF MOTION OF HEAD. DUE TO IMPLANT FAILURES THE PATIENT HAD ADDITIONAL SURGERIES WHICH INVOLVED ADDING SYNTHES DEVICES TO THE COMPETITOR PRODUCTS THAT WERE INITIALLY PLACED. DURING A SERIES OF REVISION AND CORRECTIVE SPINE PROCEDURES, THE SURGEON OBSERVED HARDWARE FAILURE AT THE CERVICOTHORACIC JUNCTION, INCLUDING DISLODGMENT AND DISTRACTION OF POSTERIOR INSTRUMENTATION RODS, SEVERE KYPHOSIS, AND ANTEROLISTHESIS AT C3-C4. THE CERVICAL COMPONENT OF BOTH CONNECTORS DISPLACED, RESULTING IN KYPHOSIS AND FORWARD NECK POSTURE. THE RODS CONNECTING THE CERVICAL TO THORACIC SPINE PULLED OUT BILATERALLY, AND MISALIGNMENT OF BILATERAL UPPER CERVICAL RODS WITH THEIR CORRESPONDING CONNECTORS AT C5-C6 WAS NOTED. THE PATIENT REQUIRED MULTIPLE CORRECTIVE INVASIVE PROCEDURES, INCLUDING DEVICE REVISION AND REPLACEMENT. TIMELINE OF EVENTS: (B)(6) 2020-SURGIC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intervertebral Disc Compression or Protrusion

  MAUDE report 25563652 ↗
• MalfunctionMay 20, 2026Material Twisted/Bent

  IT WAS REPORTED THE INSTRUMENTS WERE WORN DUE TO REPEATED USE. NO SURGICAL DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228010 ↗
• MalfunctionMay 20, 2026Material Twisted/Bent

  IT WAS REPORTED THE INSTRUMENTS WERE WORN DUE TO REPEATED USE. NO SURGICAL DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228004 ↗
• MalfunctionMay 20, 2026Material Twisted/Bent

  IT WAS REPORTED THE INSTRUMENTS WERE WORN DUE TO REPEATED USE. NO SURGICAL DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25227996 ↗
• MalfunctionMay 20, 2026Material Twisted/Bent

  IT WAS REPORTED THE INSTRUMENTS WERE WORN DUE TO REPEATED USE. NO SURGICAL DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25227977 ↗
• MalfunctionMay 20, 2026Material Twisted/Bent

  IT WAS REPORTED THE INSTRUMENTS WERE WORN DUE TO REPEATED USE. NO SURGICAL DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25227976 ↗
• MalfunctionMay 15, 2026Material Twisted/Bent

  INSTRUMENTS WORN DUE TO REPEATED USE. AXIAL CON 3.5-4 TO 5.5-6.35 (102019004) : SIDE AFFECTED: UNKNOWN REASON PRODUCT IS NOT AVAILABLE: DISCARDED. ADJUSTABLE CON 3.5-4 TO 5.5 (102018002) : SIDE AFFECTED: UNKNOWN REASON PRODUCT IS NOT AVAILABLE: DISCARDED. PARALL CON 3.5-4 TO 3.5-4 L (102015111) : SIDE AFFECTED: UNKNOWN REASON PRODUCT IS NOT AVAILABLE: DISCARDED. 3.5MM STD THREAD NAV TAP (301019029) : SIDE AFFECTED: UNKNOWN REASON PRODUCT IS NOT AVAILABLE: DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25193756 ↗
• InjuryMay 20, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, A REVISION CASE WAS REPORTED FOR SET SCREWS DUE TO PRODUCT FAILURE. PATIENT COMPLAINS OF PAIN. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) NUMBER OF DEVICES. THIS REPORT IS FOR (1) AXIAL CON 3.5-4 TO 5.5-6.35. THIS REPORT IS 6 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11859388 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A REVISION CASE WAS REPORTED FOR SET SCREWS DUE TO PRODUCT FAILURE. PATIENT COMPLAINS OF PAIN. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) NUMBER OF DEVICES. THIS REPORT IS FOR (1) AXIAL CON 3.5-4 TO 5.5-6.35. THIS REPORT IS 2 OF 7 (B)(4).

  Patient problems: Pain

  MAUDE report 11859279 ↗