SYMPHONY 2020-00-504Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10705034532813), received between Apr 23, 2020 and Aug 18, 2026 — classified as 58 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (56 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Calibration Problem

  Patient problems: Insufficient Information

  MAUDE report 50308243 ↗
• MalfunctionAug 18, 2026Calibration Problem

  Patient problems: Insufficient Information

  MAUDE report 50308241 ↗
• MalfunctionAug 18, 2026Calibration Problem

  Patient problems: Insufficient Information

  MAUDE report 50308229 ↗
• MalfunctionDec 4, 2025Calibration Problem; Calibration Problem

  ADDITIONAL INFORMATION RECEIVED: THESE IMPACTED PRODUCTS ARE RESULT FROM ANNUAL TORQUE TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715125 ↗
• MalfunctionDec 4, 2025Calibration Problem; Calibration Problem

  ADDITIONAL INFORMATION RECEIVED: THESE IMPACTED PRODUCTS ARE RESULT FROM ANNUAL TORQUE TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715098 ↗
• MalfunctionJun 26, 2025Corroded; Mechanical Jam; Corroded; Mechanical Jam

  IT WAS REPORTED THAT THE HANDLES NEEDED REPLACING DUE TO RUST AND RATCHETING PORTION BEING STUCK. THERE WAS NO PATIENT INVOLVEMENT. ISSUE WAS NOTED PRE-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335990 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A (B)(6) FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038465 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038430 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2025. DURING FINAL TORQUE ON SYMPHONY IMPLANTS, THE SURGEON FELT A TOGGLE OF THE SCREWDRIVER SHAFT IN THE TORQUE DRIVER HANDLE. IT WAS REPLACED WITH A SECOND TORQUE DRIVER HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO MEDICAL INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 22036211 ↗
• MalfunctionSep 5, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT ITEM WAS FOUND TO BE OUT OF DRAWING SPECIFIC. THE DRAWING SPECIFICATION TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) AO HANDLE TORQUE LIMITING3.0NM FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20149265 ↗
• MalfunctionSep 5, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT THE 3.0 NM HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION; THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148120 ↗
• MalfunctionSep 5, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT THE 3.0 NM, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) AO HANDLE TORQUE LIMITING3.0NM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147649 ↗
• MalfunctionSep 4, 2024Calibration Problem; Calibration Problem

  DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT 3.0 NM-HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS IS REPORT 1 OF 1 AO HANDLE TORQUE LIMITING3.0NM FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20141185 ↗
• MalfunctionSep 4, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE SITE, IT WAS OBSERVED THAT THE HANDLE HAD BEEN FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM AO HANDLE, TORQUE LIMITING 3.0NM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134465 ↗
• MalfunctionAug 29, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT 2020-00-504, 3.0 NM HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) AO HANDLE TORQUE LIMITING3.0NM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20103208 ↗
• MalfunctionAug 28, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT THE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) AO HANDLE TORQUE LIMITING3.0NM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091198 ↗
• MalfunctionAug 28, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT 3.0 NM HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) AO HANDLE TORQUE LIMITING 3.0NM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091053 ↗
• MalfunctionAug 28, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED ON JUL 31, 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) AO HANDLE TORQUE LIMITING3.0NM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091014 ↗
• MalfunctionAug 28, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED TO THE REPAIR SITE. A REPLACEMENT DEVICE HAS BEEN ORDERED. NO REPLACEMENT PRODUCT IS REQUIRED, AND NO SHIPPING LABEL IS REQUIRED FOR THE PRODUCT RETURN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) AO HANDLE TORQUE LIMITING3.0NM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089227 ↗
• MalfunctionAug 26, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON JULY 30, 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE N.M HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION OF THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) AO HANDLE TORQUE LIMITING3.0NM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072206 ↗
• MalfunctionAug 23, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE 3.0 NM HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SYMPHONY OCT SYSTEM AO HANDLE, TORQUE LIMITING 3.0NM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055136 ↗
• MalfunctionAug 23, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE SITE, IT WAS OBSERVED THAT 3.0 NM HANDLE, WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) AO HANDLE TORQUE LIMITING3.0NM. THIS IS REPORT 1 OF 1 FOR COMPLAINT(B)(4). PC-001662281

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20046724 ↗
• MalfunctionAug 22, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON JULY 26, 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED ITEM WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) AO HANDLE TORQUE LIMITING3.0NM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041422 ↗
• MalfunctionAug 21, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON JULY 19, 2024, IT WAS OBSERVED THAT THE AO HANDLE TORQUE LIMITING3.0NM WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR AN AO HANDLE TORQUE LIMITING3.0NM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20016310 ↗
• MalfunctionAug 21, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON (B)(6)2024, IT WAS OBSERVED THAT A 3.0 NM T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR AN AO HANDLE TORQUE LIMITING3.0NM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015478 ↗