SYMPHONY 2020-00-140Recalls & reported problems
Medos International Sàrl · SYMPHONY OCT SYSTEM REDUCER KERRISON · Class 1
All models of SYMPHONY (113)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705034530567), received between Jun 26, 2020 and Apr 22, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (16 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility16
- Material Deformation2
- Mechanical Jam2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE KERRISON REDUCER WILL NOT ATTACH TO SCREW HEADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958059 ↗MalfunctionApr 22, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE KERRISON REDUCER WILL NOT ATTACH TO SCREW HEADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958057 ↗MalfunctionApr 22, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE KERRISON REDUCER WILL NOT ATTACH TO SCREW HEADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958052 ↗MalfunctionApr 22, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE KERRISON REDUCER WILL NOT ATTACH TO SCREW HEADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958051 ↗MalfunctionApr 22, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE KERRISON REDUCER WILL NOT ATTACH TO SCREW HEADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958033 ↗MalfunctionDec 30, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THIS WAS A POSTERIOR CERVICAL FUSION(C3-T2) FOR METASTASIS ON (B)(6) 2025. THE SURGEON TRIED TO USE THE REDUCER KERRISON TO PERFORM ROD CLOSURE, BUT IT WAS NOT POSSIBLE TO FIT IT ONTO THE SCREW HEAD. THE DOCTOR POINTED OUT DURING THE SURGERY THAT THE SIZE OF THE SCREW HEAD DID NOT MATCH THE SIZE OF THE INSTRUMENT'S MOUNTING PORT, SO IT WOULD NOT FIT IN THE FIRST PLACE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920742 ↗MalfunctionMay 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING A C3-T1 PCF ON AN UNKNOWN DATE, IT WAS NOTED THAT A LOT OF DAMAGE TO THE INSTRUMENTS HAS BEEN FOUND FROM USAGE OVER TIME. THE FINAL TIGHTENERS WERE STRIPPED BECAUSE THEY WEREN'T SEATED COMPLETED IN THE SET CAP WHEN ATTEMPTING TO FINAL TIGHTEN. SIMILARLY, THE SET CAP INSERTERS WERE NOT IN THE SAME PLANE AS THE SCREW BUT THE SURGEON KEPT TRYING TO FASTEN THEM DOWN WHICH STRIPPED THE SET CAP INSERTER. ADDITIONALLY, THE PERSUADER (REDUCER) GOT STUCK ON THE SCREW HEAD AND BENT IT WHEN SURGEON TRIED TO REMOVE IT SO IT NO LONGER CLIPS ON TO OTHER SCREWS. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061209 ↗MalfunctionNov 8, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PERSUADER IS NOT GRABBING ONTO TO SCREW HEADS TO REDUCE. SURGERY WAS NOT DELAYED AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20641261 ↗MalfunctionSep 18, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE. THE REDUCER KERRISON WOULD NOT ATTACH TO THE TOP NOTCH OF THE TULIP. THE ROD WAS NOT ABLE TO BE PUT IN THE TULIP AS THE REDUCER KERRISON KEPT DISENGAGING/NOT LOCKING ON TO THE TULIP TO REDUCE THE ROD. THERE WAS FIVE MINUTES SURGICAL DELAY DUE TO REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A REDUCER KERRISON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20251379 ↗MalfunctionAug 14, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE KERRISON REDUCER BROKEN DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SYMPHONY OCT SYSTEM REDUCER KERRISON. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19985294 ↗MalfunctionApr 5, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT ON (B)(6) 2024 THE INSTRUMENT FROZE AND WOULD NOT ALLOW THE DRIVER TO MOVE FORWARD OR BACKWARD. THE INSTRUMENT WAS REMOVED BEFORE CASE STARTED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SYMPHONY OCT SYSTEM REDUCER KERRISON. THIS IS REPORT 2 OF 2 FOR (B)(4) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049378 ↗MalfunctionApr 5, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT ON (B)(6) 2024 THE INSTRUMENT FROZE AND WOULD NOT ALLOW THE DRIVER TO MOVE FORWARD OR BACKWARD. THE INSTRUMENT WAS REMOVED BEFORE CASE STARTED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SYMPHONY OCT SYSTEM REDUCER KERRISON. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049356 ↗MalfunctionNov 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE REDUCER WON¿T GRAB TOP NOTCH OF SCREW AND ROD FOUND TO BE BENT BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCER KERRISON THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18141355 ↗MalfunctionNov 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE REDUCER WON¿T GRAB TOP NOTCH OF SCREW AND ROD FOUND TO BE BENT BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCER KERRISON. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18141354 ↗MalfunctionNov 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE REDUCER WON¿T GRAB TOP NOTCH OF SCREW AND ROD FOUND TO BE BENT BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCER KERRISON. THIS IS REPORT 1 OF 3 FOR COMPLAINT PC-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18141331 ↗MalfunctionMar 1, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT IT SEEMS TO BE DIFFICULT TO ATTACH TO THE SCREW AND THEN STICKS SOMETIMES AFTERWARDS. THE PART NUMBER IS 202000140. THIS REPORT IS FOR ONE (1) REDUCER KERRISON. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16460232 ↗MalfunctionFeb 28, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE KERRISON REDUCER FROM SYMPHONY SEEMS TO BE DIFFICULT TO ATTACH TO THE SCREW AND THEN STICKS SOMETIMES AFTERWARDS. THIS REPORT IS FOR ONE (1) SYMPHONY OCT SYSTEM REDUCER KERRISON THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16455954 ↗MalfunctionDec 28, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR SPINAL FUSION SURGERY. THE SURGEON WAS PERFORMING A POSTERIOR CERVICAL FUSION WITH DEPUY SYNTHES SPINE SYMPHONY. DURING PLACEMENT OF THE RODS, THE SURGEON COULD NOT GET THE INSTRUMENT TO ENGAGE THE SCREW WITHOUT COMING OFF. THE INSTRUMENT IS SQUEEZED AND ENGAGED; THE TIPS MAY NOT BE MOVING ENOUGH TO CAPTURE THE SCREW ADEQUATELY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH 3-MINUTES DELAY. NOT HARM OR ISSUES WITH THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) REDUCER KERRISON. THIS REPORT IS 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13101647 ↗MalfunctionJun 26, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED DURING A SPINAL FUSION PROCEDURE ON AN UNKNOWN DATE IN 2020, THE KERRISON REDUCER FOR SYMPHONY WAS DISLODGING OR DISCONNECTING UPON REDUCTION OF A 4.0 ROD. THERE WAS NO SURGICAL DELAY. THERE WERE NO KNOWN PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK UP INSTRUMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN 4.0 ROD (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10199766 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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