SYMPHONY 1020-00-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034514352), received between May 20, 2021 and Jun 22, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Migration” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2020, THE PATIENT WAS INVOLVED IN A CAR COLLISION AND WAS AIRLIFTED TO (B)(6). THE PATIENT HAD ORIGINAL SURGERY IN (B)(6) 2020. THE ORIGINAL SURGERY DID NOT INVOLVE ANY SYNTHES DEVICES. DUE TO IMPLANT FAILURES THE PATIENT HAD ADDITIONAL SURGERIES WHICH INVOLVED ADDING SYNTHES DEVICES TO THE COMPETITOR PRODUCTS THAT WERE INITIALLY PLACED. ON (B)(6) 2020, THE PATIENT UNDERWENT AN OCCIPUT-C3 POSTERIOR SPINAL FUSION WHERE BONE SCREWS AND TITANIUM RODS WERE PLACED IN HER CERVICAL SPINE. THE PROCEDURE WAS PERFORMED PURSUANT TO THE STANDARD OF CARE AND PATIENT TOLERATED THE PROCEDURE WELL. PATIENT'S PHYSICAL AND MENTAL HEALTH IMPROVED GREATLY AFTER THIS SURGERY. ON (B)(6) 2020, THE PATIENT INFORMED (B)(6) ABOUT THE VEHICULAR COLLISION AND REQUESTED PAIN MANAGEMENT. ON (B)(6) 2020, X-RAYS LEFT THE IMPRESSION OF AN INSTRUMENTED POSTERIOR SPINAL FUSION AND POSTERIOR DECOMPRESSION FROM THE OCCIPUT THROUGH C3 FOR MANAGEMENT OF CERVICAL SPINE FRACTURES. ALSO, X-RAYS HER RIGHT SHOULDER SHOWED CLAVICULAR FRACTURE AND THORACIC COMPRESSION FRACTURES AT THE T5 AND T6 LEVELS. PATIENT WAS DIAGNOSED WITH A CLOSED STABLE BURST FRACTURE OF FIRST CERVICAL VERTEBRAE WITH ROUTINE HEALING. ON (B)(6

  Patient problems: Bone Fracture(s); Depression; Fatigue; Impaired Healing; Inflammation; Loss of Range of Motion; Numbness; Pain; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 25583557 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 IT WAS NOTED THAT SINCE SURGERY AND EXTUBATION, THE PATIENT'S MENTAL STATUS HAS BEEN ALTERED. INITIALLY (B)(6) - (B)(6) THE PATIENT WAS MORE LETHARGIC BUT BY DOCUMENTATION SEEMED TO HAVE A FLUCTUATING LEVEL OF AROUSAL/ALERTNESS AND SOME DISORIENTATION. STARTING JULY 9 AND INTO JULY 10, THE PATIENT HAS HAD PROGRESSIVE WORSENING OF AGITATION, SLEEP DISTURBANCE, AND DISORIENTATION, AS WELL AS NEW HALLUCINATIONS, ILLUSIONS AND DELUSIONS. DURING THIS PERIOD THE PATIENT'S MENTAL STATUS WAS WAXING AND WANING. ON (B)(6) 2020 THE PATIENT WAS RELEASED FROM THE HOSPITAL. ON (B)(6) 2020, X-RAYS WERE TAKEN WHICH SHOWED MULTIPLE THORACIC BURST/COMPRESSION FRACTURES, MOST SEVERE AT T6. ON (B)(6) 2020 THE SURGEON NOTED THAT: SHE DID FAIRLY WELL EARLY ON REGAINING SOME OF HER NEUROLOGIC FUNCTION SHE HAD LOST THROUGH PHYSICAL THERAPY BUT THEN HAD COLLAPSE THROUGH HER MIDTHORACIC SPINE. ON (B)(6) 2020 THE SURGEON NOTED THAT: WE INITIALLY INTERVENED TO STOP THE COLLAPSE OF HER THORACIC FRACTURES BY FUSING HER FROM T3-T9. SHE DID WELL INITIALLY AND THEN QUICKLY HER SOFT TISSUES HAD HER CERVICOTHORACIC JUNCTION FAILED. THIS LEFT US NO CHOICE BUT TO INTERVENE BY FUSING

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Nonunion/Delayed-union Bone Fracture; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Vertebral Fracture

  MAUDE report 20077303 ↗
• InjuryDec 3, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, UNDERWENT A REVISION SURGERY TO CORRECT THE SET SCREW FROM BEING DIS-LODGED AND MAKING NOISE AS THE PATIENT MOVED HIS NECK. THE PATIENT HAD A FUSION IN OCTOBER AND WHEN HE BENT OVER, HE HEARD A POP AND FELT SOME SLIGHT DISCOMFORT. HE PRESENTED WITH A LOCKING CAP DIS-LODGED FROM HIS C7 PEDI LEFT SCREW WITH RADIOLOGIC CONFIRMATION AND THE SET SCREW WAS DISLODGED FROM THE POLY SCREW. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SET SCREW. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12924998 ↗
• InjuryDec 3, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, UNDERWENT A REVISION SURGERY TO CORRECT THE SET SCREW FROM BEING DIS-LODGED AND MAKING NOISE AS THE PATIENT MOVED HIS NECK. THE PATIENT HAD A FUSION IN OCTOBER AND WHEN HE BENT OVER, HE HEARD A POP AND FELT SOME SLIGHT DISCOMFORT. HE PRESENTED WITH A LOCKING CAP DIS-LODGED FROM HIS C7 PEDI LEFT SCREW WITH RADIOLOGIC CONFIRMATION AND THE SET SCREW WAS DISLODGED FROM THE POLY SCREW. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SET SCREW. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12924937 ↗
• InjuryDec 3, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, UNDERWENT A REVISION SURGERY TO CORRECT THE SET SCREW FROM BEING DIS-LODGED AND MAKING NOISE AS THE PATIENT MOVED HIS NECK. THE PATIENT HAD A FUSION IN OCTOBER AND WHEN HE BENT OVER, HE HEARD A POP AND FELT SOME SLIGHT DISCOMFORT. HE PRESENTED WITH A LOCKING CAP DIS-LODGED FROM HIS C7 PEDI LEFT SCREW WITH RADIOLOGIC CONFIRMATION AND THE SET SCREW WAS DISLODGED FROM THE POLY SCREW. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SET SCREW. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12924912 ↗
• InjuryDec 3, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, UNDERWENT A REVISION SURGERY TO CORRECT THE SET SCREW FROM BEING DIS-LODGED AND MAKING NOISE AS THE PATIENT MOVED HIS NECK. THE PATIENT HAD A FUSION IN OCTOBER AND WHEN HE BENT OVER, HE HEARD A POP AND FELT SOME SLIGHT DISCOMFORT. HE PRESENTED WITH A LOCKING CAP DIS-LODGED FROM HIS C7 PEDI LEFT SCREW WITH RADIOLOGIC CONFIRMATION AND THE SET SCREW WAS DISLODGED FROM THE POLY SCREW. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SET SCREW. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12924873 ↗
• InjuryDec 3, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, UNDERWENT A REVISION SURGERY TO CORRECT THE SET SCREW FROM BEING DIS-LODGED AND MAKING NOISE AS THE PATIENT MOVED HIS NECK. THE PATIENT HAD A FUSION IN (B)(6) AND WHEN HE BENT OVER, HE HEARD A POP AND FELT SOME SLIGHT DISCOMFORT. HE PRESENTED WITH A LOCKING CAP DIS-LODGED FROM HIS C7 PEDI LEFT SCREW WITH RADIOLOGIC CONFIRMATION AND THE SET SCREW WAS DISLODGED FROM THE POLY SCREW. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SET SCREW. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12924871 ↗
• 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) SET SCREW. THIS REPORT IS 5 OF 7 (B)(4).

  Patient problems: Pain

  MAUDE report 11859402 ↗
• 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) SET SCREW. THIS REPORT IS 1 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11859342 ↗
• 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) SET SCREW. THIS REPORT IS 4 OF 7 (B)(4).

  Patient problems: Pain

  MAUDE report 11859341 ↗
• 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) SET SCREW. THIS REPORT IS 3 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11859287 ↗