SYMPHONY 2020-00-154Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034530642), received between Oct 28, 2022 and Sep 24, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TAB BREAKER WOULD NOT SLIDE ONTO TABS AND BENT. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE REDUCTION TAB BREAKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291245 ↗
• MalfunctionSep 24, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE EVENT OCCURRED DURING POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291227 ↗
• MalfunctionSep 24, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE EVENT OCCURRED DURING POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291175 ↗
• MalfunctionSep 24, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TAB BREAKER WOULD NOT SLIDE ONTO TABS AND BENT. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE REDUCTION TAB BREAKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291109 ↗
• MalfunctionJan 16, 2024Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: ON (B)(6) 2023, A SPINE FUSION FOR CERVICAL DISLOCATION WAS PERFORMED, THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY ON 25-DECEMBER-2023, DURING THE INSTRUMENT CLEANING PROCESS, BROKEN TABS REMAINING IN THE REDUCTION TAB BREAKER IN QUESTION COULD NOT BE REMOVED. THE MOVEMENT OF THE BREAKER WAS ALSO IMPACTED, AND THE SALES REP DECIDED THAT IT SHOULD NOT BE USED IN THE NEXT OPERATION. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM REDUCTION TAB BREAKER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517551 ↗
• InjuryOct 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2022. WHEN THE SURGEON REMOVED THE TAB OF THE REDUCTION TAB SCREW WITH THE REDUCTION TAB BREAKER IN QUESTION, THE TAB BREAKER SLIPPED AND CONTACTED A NERVE. THEN, WAVEFORM DID NOT APPEAR IN THE MEP MONITORING AT ALL. ALTHOUGH THE SURGEON WAITED FOR 15 MINUTES AFTER SALINE SOLUTION WAS ADDED TO THE SURGICAL FIELD, THE MEP MONITORING DID NOT SHOW THE WAVEFORM. A LITTLE ADDITIONAL DECOMPRESSION WAS PERFORMED, AND THE WOUND WAS CLOSED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM REDUCTION TAB BREAKER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 15691487 ↗