SYMPHONY 1020-35-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034508689), received between Jan 14, 2021 and Oct 15, 2025 — classified as 6 deaths, 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD PRIMARY SURGERY ON SEPTEMBER 4, RETURNED HOME ON SEPTEMBER 8, AND FELL HARD ON SEPTEMBER 12. POSTERIOR C3 SCREWS HAVE APPEARED TO HAVE PULLED OUT. ORIGINAL PLAN WAS TO REPLACE C3 SCREWS BUT SETS WERE CONTAMINATED SO SURGEON DECIDED TO NOT WAIT FOR OUR SETS TO BE RESTERILIZED AND CHOSE TO USE COMPETITOR SCREWS AT C3 AND PLACED A NEW ROD (LEAVING REMAINING SYMPHONY SCREWS IN PLACE) RETORQUING ENTIRE CONSTRUCT.

  Patient problems: Fall; Insufficient Information

  MAUDE report 23301670 ↗
• MalfunctionOct 15, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD PRIMARY SURGERY ON SEPTEMBER 4, RETURNED HOME ON SEPTEMBER 8, AND FELL HARD ON SEPTEMBER 12. POSTERIOR C3 SCREWS HAVE APPEARED TO HAVE PULLED OUT. ORIGINAL PLAN WAS TO REPLACE C3 SCREWS BUT SETS WERE CONTAMINATED SO SURGEON DECIDED TO NOT WAIT FOR OUR SETS TO BE RESTERILIZED AND CHOSE TO USE COMPETITOR SCREWS AT C3 AND PLACED A NEW ROD (LEAVING REMAINING SYMPHONY SCREWS IN PLACE) RETORQUING ENTIRE CONSTRUCT.

  Patient problems: Fall; Insufficient Information

  MAUDE report 23301609 ↗
• InjuryJan 17, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT ALMOST ALL INNER SCREWS FROM A SYMPHONY CONSTRUCTION DETACHED FROM THE HEAD OF THE SCREW. THE FIRST SURGERY WAS ON (B)(6) 2024 AND IN POST OP EXAM IT WAS VERIFIED THAT CONSTRUCTION FAILED WITH THE LOOSE LOCKING SCREWS. ALMOST ALL PEDICLE SCREWS REMAINED ON PLACE. NON-UNION WAS ALSO NOTED. THE PATIENT UNDERWENT REVISION SURGERY, WHICH WENT WELL.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21180121 ↗
• InjuryJan 15, 2025Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED THAT ALMOST ALL INNER SCREWS FROM A SYMPHONY CONSTRUCTION DETACHED FROM THE HEAD OF THE SCREW. THE FIRST SURGERY WAS ON (B)(6) 2024 AND IN POST OP EXAM IT WAS VERIFIED THAT CONSTRUCTION FAILED WITH THE LOOSE LOCKING SCREWS. ALMOST ALL PEDICLE SCREWS REMAINED ON PLACE.

  Patient problems: Insufficient Information

  MAUDE report 21158309 ↗
• InjuryJan 15, 2025Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED THAT ALMOST ALL INNER SCREWS FROM A SYMPHONY CONSTRUCTION DETACHED FROM THE HEAD OF THE SCREW. THE FIRST SURGERY WAS ON (B)(6) 2024 AND IN POST OP EXAM IT WAS VERIFIED THAT CONSTRUCTION FAILED WITH THE LOOSE LOCKING SCREWS. ALMOST ALL PEDICLE SCREWS REMAINED ON PLACE.

  Patient problems: Insufficient Information

  MAUDE report 21158285 ↗
• InjuryJan 15, 2025Break; Device Slipped; Break; Device Slipped

  IT WAS REPORTED THAT ALMOST ALL INNER SCREWS FROM A SYMPHONY CONSTRUCTION DETACHED FROM THE HEAD OF THE SCREW. THE FIRST SURGERY WAS ON (B)(6) 2024 AND IN POST OP EXAM IT WAS VERIFIED THAT CONSTRUCTION FAILED WITH THE LOOSE LOCKING SCREWS. ALMOST ALL PEDICLE SCREWS REMAINED ON PLACE.

  Patient problems: Insufficient Information

  MAUDE report 21158265 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JULY 13, 2020 IT WAS NOTED THAT SINCE SURGERY AND EXTUBATION, THE PATIENT'S MENTAL STATUS HAS BEEN ALTERED. INITIALLY (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 BETWEE

  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 20077625 ↗
• InjuryJul 12, 2022Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION SURGERY ON (B)(6) 2022, THE SHANK OF A SYMPHONY POSTERIOR CERVICAL SCREW BROKE UPON INSERTION INTO THE C7 LATERAL MASS. BEFORE PLACING THE SCREW, THE HOLE WAS DRILLED AND TAPPED WITH A 3MM TAP. THE SCREW WAS LEFT IN THE PATIENT, NO SURGICAL DELAY OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X12MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14991127 ↗
• InjurySep 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR A REVISION SURGERY DUE TO SCREW FAILURE. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THE PATIENT HAD A NECK REPAIR FOR A C2 FRACTURE IN AN UNKNOWN DATE OF (B)(6) 2021. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) MNTR OC SCREW 4.5 X 10. THIS REPORT IS 4 OF 4 FOR (B)(4).

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

  MAUDE report 12428507 ↗
• DeathJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (B)(6) 2020 DURING POSTERIOR CERVICAL FUSION SURGERY THE PATIENT DIED. THE DEPUY SYNTHES SPINE SYSTEM UTILIZED IN THIS PROCEDURE WAS THE SYMPHONY OCT SYSTEM. THE INSTRUMENTATION OF THE SYMPHONY SCREWS WAS UNEVENTFUL. THE SURGEON FIRST INSTRUMENTED C4-6 LATERAL MASSES, THEN C2 PARS, AND FINALLY T1 PEDICLES. ALL SCREW PLACEMENTS WERE CONFIRMED BY THE SURGEON WITH FLUOROSCOPY. THE SURGEON PROCEEDED TO PERFORM THE DECOMPRESSION WITH A C3-7 LAMINECTOMY. AFTERWARDS THE SURGEON CHANGED THE VECTOR OF THE PATIENTS HEAD TO RE-ALIGN THE SPINE AFTER DECOMPRESSION. APPROXIMATELY TEN (10) MINUTES AFTERWARDS HE BEGAN PREPARING TWO (2) 4.0MM RODS. PRIOR TO INSTRUMENTATION OF THE RODS, THE PATIENT BEGAN TO LOSE SENSORY NEUROMONITORING SIGNALS. APPROXIMATELY FIVE (5) MINUTES LATER THE PATIENT LOSES MOTOR SIGNALS AND LOW BLOOD PRESSURE. AT THIS MOMENT THERE IS AN URGENCY TO COMPLETE THE CONSTRUCT AND CLOSE THE PATIENT. THE SURGEON DECIDED TO USE 3.5MM RODS INSTEAD. ALL RODS AND SET SCREWS WERE IMPLANTED AND FINAL TIGHTENED AS INTENDED. THE PATIENT WENT INTO CARDIAC ARREST APPROXIMATELY 5 MINUTES INTO CLOSING. APPROXIMATELY 1 HOUR AFTERWARDS, TIME OF DEATH WAS ANNOUNCED. THERE WA

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

  MAUDE report 11177399 ↗
• DeathJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (B)(6) 2020, DURING POSTERIOR CERVICAL FUSION SURGERY THE PATIENT DIED. THE DEPUY SYNTHES SPINE SYSTEM UTILIZED IN THIS PROCEDURE WAS THE SYMPHONY OCT SYSTEM. THE INSTRUMENTATION OF THE SYMPHONY SCREWS WAS UNEVENTFUL. THE SURGEON FIRST INSTRUMENTED C4-6 LATERAL MASSES, THEN C2 PARS, AND FINALLY T1 PEDICLES. ALL SCREW PLACEMENTS WERE CONFIRMED BY THE SURGEON WITH FLUOROSCOPY. THE SURGEON PROCEEDED TO PERFORM THE DECOMPRESSION WITH A C3-7 LAMINECTOMY. AFTERWARDS THE SURGEON CHANGED THE VECTOR OF THE PATIENT¿S HEAD TO RE-ALIGN THE SPINE AFTER DECOMPRESSION. APPROXIMATELY TEN (10) MINUTES AFTERWARDS HE BEGAN PREPARING TWO (2) 4.0MM RODS. PRIOR TO INSTRUMENTATION OF THE RODS, THE PATIENT BEGAN TO LOSE SENSORY NEUROMONITORING SIGNALS. APPROXIMATELY FIVE (5) MINUTES LATER THE PATIENT LOSES MOTOR SIGNALS AND LOW BLOOD PRESSURE. AT THIS MOMENT THERE IS AN URGENCY TO COMPLETE THE CONSTRUCT AND CLOSE THE PATIENT. THE SURGEON DECIDED TO USE 3.5MM RODS INSTEAD. ALL RODS AND SET SCREWS WERE IMPLANTED AND FINAL TIGHTENED AS INTENDED. THE PATIENT WENT INTO CARDIAC ARREST APPROXIMATELY 5 MINUTES INTO CLOSING. APPROXIMATELY 1 HOUR AFTERWARDS, TIME OF DEATH WAS ANNOUNCED. THERE W

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

  MAUDE report 11177292 ↗
• DeathJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (B)(6) 2020, DURING POSTERIOR CERVICAL FUSION SURGERY THE PATIENT DIED. THE DEPUY SYNTHES SPINE SYSTEM UTILIZED IN THIS PROCEDURE WAS THE SYMPHONY OCT SYSTEM. THE INSTRUMENTATION OF THE SYMPHONY SCREWS WAS UNEVENTFUL. THE SURGEON FIRST INSTRUMENTED C4-6 LATERAL MASSES, THEN C2 PARS, AND FINALLY T1 PEDICLES. ALL SCREW PLACEMENTS WERE CONFIRMED BY THE SURGEON WITH FLUOROSCOPY. THE SURGEON PROCEEDED TO PERFORM THE DECOMPRESSION WITH A C3-7 LAMINECTOMY. AFTERWARDS THE SURGEON CHANGED THE VECTOR OF THE PATIENTS HEAD TO RE-ALIGN THE SPINE AFTER DECOMPRESSION. APPROXIMATELY TEN (10) MINUTES AFTERWARDS HE BEGAN PREPARING TWO (2) 4.0MM RODS. PRIOR TO INSTRUMENTATION OF THE RODS, THE PATIENT BEGAN TO LOSE SENSORY NEUROMONITORING SIGNALS. APPROXIMATELY FIVE (5) MINUTES LATER THE PATIENT LOSES MOTOR SIGNALS AND LOW BLOOD PRESSURE. AT THIS MOMENT THERE IS AN URGENCY TO COMPLETE THE CONSTRUCT AND CLOSE THE PATIENT. THE SURGEON DECIDED TO USE 3.5MM RODS INSTEAD. ALL RODS AND SET SCREWS WERE IMPLANTED AND FINAL TIGHTENED AS INTENDED. THE PATIENT WENT INTO CARDIAC ARREST APPROXIMATELY 5 MINUTES INTO CLOSING. APPROXIMATELY 1 HOUR AFTERWARDS, TIME OF DEATH WAS ANNOUNCED. THERE W

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

  MAUDE report 11177259 ↗
• DeathJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (B)(6) 2020, DURING POSTERIOR CERVICAL FUSION SURGERY THE PATIENT DIED. THE DEPUY SYNTHES SPINE SYSTEM UTILIZED IN THIS PROCEDURE WAS THE SYMPHONY OCT SYSTEM. THE INSTRUMENTATION OF THE SYMPHONY SCREWS WAS UNEVENTFUL. THE SURGEON FIRST INSTRUMENTED C4-6 LATERAL MASSES, THEN C2 PARS, AND FINALLY T1 PEDICLES. ALL SCREW PLACEMENTS WERE CONFIRMED BY THE SURGEON WITH FLUOROSCOPY. THE SURGEON PROCEEDED TO PERFORM THE DECOMPRESSION WITH A C3-7 LAMINECTOMY. AFTERWARDS THE SURGEON CHANGED THE VECTOR OF THE PATIENTS HEAD TO RE-ALIGN THE SPINE AFTER DECOMPRESSION. APPROXIMATELY TEN (10) MINUTES AFTERWARDS HE BEGAN PREPARING TWO (2) 4.0MM RODS. PRIOR TO INSTRUMENTATION OF THE RODS, THE PATIENT BEGAN TO LOSE SENSORY NEUROMONITORING SIGNALS. APPROXIMATELY FIVE (5) MINUTES LATER THE PATIENT LOSES MOTOR SIGNALS AND LOW BLOOD PRESSURE. AT THIS MOMENT THERE IS AN URGENCY TO COMPLETE THE CONSTRUCT AND CLOSE THE PATIENT. THE SURGEON DECIDED TO USE 3.5MM RODS INSTEAD. ALL RODS AND SET SCREWS WERE IMPLANTED AND FINAL TIGHTENED AS INTENDED. THE PATIENT WENT INTO CARDIAC ARREST APPROXIMATELY 5 MINUTES INTO CLOSING. APPROXIMATELY 1 HOUR AFTERWARDS, TIME OF DEATH WAS ANNOUNCED. THERE W

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

  MAUDE report 11177227 ↗
• DeathJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (B)(6) 2020, DURING POSTERIOR CERVICAL FUSION SURGERY THE PATIENT DIED. THE DEPUY SYNTHES SPINE SYSTEM UTILIZED IN THIS PROCEDURE WAS THE SYMPHONY OCT SYSTEM. THE INSTRUMENTATION OF THE SYMPHONY SCREWS WAS UNEVENTFUL. THE SURGEON FIRST INSTRUMENTED C4-6 LATERAL MASSES, THEN C2 PARS, AND FINALLY T1 PEDICLES. ALL SCREW PLACEMENTS WERE CONFIRMED BY THE SURGEON WITH FLUOROSCOPY. THE SURGEON PROCEEDED TO PERFORM THE DECOMPRESSION WITH A C3-7 LAMINECTOMY. AFTERWARDS THE SURGEON CHANGED THE VECTOR OF THE PATIENTS HEAD TO RE-ALIGN THE SPINE AFTER DECOMPRESSION. APPROXIMATELY TEN (10) MINUTES AFTERWARDS HE BEGAN PREPARING TWO (2) 4.0MM RODS. PRIOR TO INSTRUMENTATION OF THE RODS, THE PATIENT BEGAN TO LOSE SENSORY NEUROMONITORING SIGNALS. APPROXIMATELY FIVE (5) MINUTES LATER THE PATIENT LOSES MOTOR SIGNALS AND LOW BLOOD PRESSURE. AT THIS MOMENT THERE IS AN URGENCY TO COMPLETE THE CONSTRUCT AND CLOSE THE PATIENT. THE SURGEON DECIDED TO USE 3.5MM RODS INSTEAD. ALL RODS AND SET SCREWS WERE IMPLANTED AND FINAL TIGHTENED AS INTENDED. THE PATIENT WENT INTO CARDIAC ARREST APPROXIMATELY 5 MINUTES INTO CLOSING. APPROXIMATELY 1 HOUR AFTERWARDS, TIME OF DEATH WAS ANNOUNCED. THERE W

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11170933 ↗
• DeathJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (B)(6) 2020, DURING POSTERIOR CERVICAL FUSION SURGERY THE PATIENT DIED. THE DEPUY SYNTHES SPINE SYSTEM UTILIZED IN THIS PROCEDURE WAS THE SYMPHONY OCT SYSTEM. THE INSTRUMENTATION OF THE SYMPHONY SCREWS WAS UNEVENTFUL. THE SURGEON FIRST INSTRUMENTED C4-6 LATERAL MASSES, THEN C2 PARS, AND FINALLY T1 PEDICLES. ALL SCREW PLACEMENTS WERE CONFIRMED BY THE SURGEON WITH FLUOROSCOPY. THE SURGEON PROCEEDED TO PERFORM THE DECOMPRESSION WITH A C3-7 LAMINECTOMY. AFTERWARDS THE SURGEON CHANGED THE VECTOR OF THE PATIENT¿S HEAD TO RE-ALIGN THE SPINE AFTER DECOMPRESSION. APPROXIMATELY TEN (10) MINUTES AFTERWARDS HE BEGAN PREPARING TWO (2) 4.0MM RODS. PRIOR TO INSTRUMENTATION OF THE RODS, THE PATIENT BEGAN TO LOSE SENSORY NEUROMONITORING SIGNALS. APPROXIMATELY FIVE (5) MINUTES LATER THE PATIENT LOSES MOTOR SIGNALS AND LOW BLOOD PRESSURE. AT THIS MOMENT THERE IS AN URGENCY TO COMPLETE THE CONSTRUCT AND CLOSE THE PATIENT. THE SURGEON DECIDED TO USE 3.5MM RODS INSTEAD. ALL RODS AND SET SCREWS WERE IMPLANTED AND FINAL TIGHTENED AS INTENDED. THE PATIENT WENT INTO CARDIAC ARREST APPROXIMATELY 5 MINUTES INTO CLOSING. APPROXIMATELY 1 HOUR AFTERWARDS, TIME OF DEATH WAS ANNOUNCED. THERE W

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11169834 ↗