SYMPHONY 1020-35-116SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705034524382), received between Dec 8, 2021 and Apr 21, 2025 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A POSTERIOR CERVICAL FUSION PERFORMED ON (B)(6) 2025. THE SYMPHONY SCRW IN QUESTION GOT STUCK INSIDE THE CLEAN CASE AND COULD NOT BE TAKEN OUT. FINALLY, BY HITTING THE CASE HARD, THE SYMPHONY SCRW IN QUESTION WAS ABLE TO BE TAKEN OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872177 ↗
• MalfunctionOct 10, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT UNDERWENT A PROCEDURE TO REMOVE BROKEN HARDWARE. DURING REMOVAL PROCEDURE IT WAS DISCOVERED THAT FIVE OF THE TEN SYMPHONY SCREWS HAD SHEARED OFF. THE SURGEON COULD NOT RETRIEVE THE BROKEN HALF OF THE SCREW AND IT WAS LEFT INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20420007 ↗
• MalfunctionOct 10, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT UNDERWENT A PROCEDURE TO REMOVE BROKEN HARDWARE. DURING REMOVAL PROCEDURE IT WAS DISCOVERED THAT FIVE OF THE TEN SYMPHONY SCREWS HAD SHEARED OFF. THE SURGEON COULD NOT RETRIEVE THE BROKEN HALF OF THE SCREW AND IT WAS LEFT INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20419966 ↗
• MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THIS WAS A POSTERIOR SPINAL FUSION (CERVICAL SPINE) FOR INJURY ON (B)(6) 2024. DURING SURGERY, AFTER CONFIRMING THAT THE SCREWDRIVER WAS ATTACHED TO THE SYMPHONY SCREW, THE SURGEON ATTEMPTED TO INSERT THE SYMPHONY SCREW. HOWEVER, THE SYMPHONY SCREW CAME OFF THE SCREWDRIVER AND BECAME UNCLEAN. THE SURGEON MENTIONED THAT THE SCREWDRIVER WAS FINE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT IS LISTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238742 ↗
• MalfunctionJul 23, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE SCREW IMPLANT COULD NOT BE TIGHTENED STRAIGHT IN THE SCREWDRIVER. IT WAS ATTEMPTED SEVERAL TIMES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X16MM 3.5 AND 4.0 THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805326 ↗
• MalfunctionNov 29, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE KIT WAS LOANED IN FROM THE WAREHOUSE, AS THE ACCOUNT DOESN¿T OWN THIS SPECIFIC INSTRUMENT AND IMPLANTS KIT. SCREW WASN¿T THREADING ON BOTH THE SCREW DRIVERS, HAD TO OPEN A NEW SCREW INSTEAD AND THAT WAS ALL FINE. BUT IT TOOK FEW MINUTES EXTRA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO IMPACT ON PATIENT. THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 3.5X16 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230717 ↗
• InjuryAug 19, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE SURGEON WAS IN THE PROCESS OF PLACING HIS LATERAL MASS SCREWS FOR AN OCCIPUT TO C5 INSTRUMENTED FUSION. FOR HIS LATERAL MASS SCREWS, HE USED A MIDAS DRILL TO START HIS SCREW HOLES. HE DID THIS AT C3, C4 AND C5. FOLLOWING THIS, HE USED FIXED DRILL GUIDES STARTING AT 14 MM IN LENGTH. HE DRILLED AT 14 MM DEPTH, BALL TIPPED, 16 MM DEPTH, BALL TIPPED, AND THEN LASTLY, DRILLED AT 18 MM DEPTH. AFTER BALL TIPPING AT 18 MM DEPTH, HE CHOSE TO PLACE 3.5 X 16 MM SYMPHONY SCREWS. WHILE PLACING HIS LEFT C5 LATERAL MASS SCREW, THE SURGEON NEEDED 1/2-1 MORE FULL REVOLUTION OF THE SCREW BEFORE HE WAS HAPPY WITH THE PLACEMENT. HE HAD DISENGAGED THE SYMPHONY SCREW DRIVER RETAINING SLEEVE. WHILE STILL HAVING THE SYMPHONY DRIVER SHAFT ENGAGED INTO THE RECESS OF THE SCREW, HE ATTEMPTED THAT 1/2 - FULL TURN. UNFORTUNATELY, IN DOING SO, THE SCREW HEAD HAD SHEERED OFF FROM THE SHANK OF THE SCREW. MULTIPLE REMOVAL TECHNIQUES WERE ATTEMPTED, BUT UNFORTUNATELY, THE SHANK OF THE SCREW WAS FLUSH WITH THE BONE INTERFACE AND WAS LEFT WITH THE PATIENT. THE SURGERY WAS NOT COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF THIRTY (30) MINUTES. PATIENT LEFT SURGERY W

  Patient problems: Foreign Body In Patient

  MAUDE report 15261210 ↗
• MalfunctionApr 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING POSTERIOR SPINAL FUSION C1-C2 PROCEDURE, THE SURGEON DESCRIBED HAVING DIFFICULTY STARTING THE SCREW DESPITE HAVING TAPPED WITH A 3.5 DIAMETER TAP. THE TIP OF THE SCREW WAS NOT ENGAGING AND ONLY AFTER TAPPING WITH A 4.0 DIAMETER TAP, THE SURGEON WAS ABLE TO INSERT THE 3.5MM DIAMETER SCREW TO ENGAGE WITH THE BONE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR (1) 4.0 PLY SCRW 3.5X16. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102710 ↗
• InjuryMar 4, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS PERFORMING POSTERIOR SURGICAL FUSION PROCEDURE USING THE SYMPHONY SYSTEM. TWO OF THE 3.5MM X 16MM LATERAL MASS SCREWS BROKE JUST BELOW THE HEAD DURING INSERTION. IT WAS REPORTED THAT THEY BROKE DURING THE FINAL ROTATION DURING INSERTION WITHOUT ANY OFF AXIS MOVEMENT OF THE DRIVER. THE FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS A TWENTY MINUTE SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X16MM 3.5 AND 4.0. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13667725 ↗
• InjuryMar 4, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THE SURGEON WAS PERFORMING POSTERIOR SURGICAL FUSION PROCEDURE USING THE SYMPHONY SYSTEM. TWO OF THE 3.5MM X 16MM LATERAL MASS SCREWS BROKE JUST BELOW THE HEAD DURING INSERTION. IT WAS REPORTED THAT THEY BROKE DURING THE FINAL ROTATION DURING INSERTION WITHOUT ANY OFF AXIS MOVEMENT OF THE DRIVER. THE FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS A TWENTY MINUTE SURGICAL DELAY. THIS REPORT IS FOR ONE (1) SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X16MM 3.5 AND 4.0. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13667720 ↗
• InjuryJan 19, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT SPINAL REOPERATION DUE TO BROKEN SYMPHONY SCREW AT C2 AND REPORTS OF PAIN. THE IMPLANT AND FRAGMENTS WERE SUCCESSFULLY REMOVED. THE INITIAL OPERATION WAS PERFORMED ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X16MM 3.5 AND 4.0. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 13288595 ↗
• MalfunctionDec 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, NURSE STRUGGLED TO LOAD SYMPHONY SCREW. DESPITE MULTIPLE ATTEMPTS THE SCREW WOULD NOT LOAD CORRECTLY AND WHEN LOADED ONTO THE SCREW DRIVER, THE SCREW SHAFT REPEATEDLY LOADED ON A OFFSET ANGLE AND NOT LOAD STRAIGHT. SURGICAL TEAM QUERIED IF THE SCREW WAS FAULTY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIVE(5) MINUTES OF SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 3.5X16. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080184 ↗
• MalfunctionDec 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A POSTERIOR CERVICAL DECOMPRESSION AND FUSION (C3-C6) TREATING OPLL, THE SELF RETAINING INSERTER WAS STUCK AND COULD NOT PULL OUT FROM THE SET SCREW WHEN THE C6 SCREW WAS INSERTED. WHEN THE INSERTER WAS PULLED MANUALLY, THE ROD, SET SCREW, AND SCREW CAME OFF ENTIRELY WHILE REMAINING ATTACHED. THE SURGEON PROCEEDED WITH THE PROCEDURE BY INSERTING A NEW SCREW WITH AN INCREASED SIZE AS WELL AS A NEW ROD AND SET SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF THIRTY (30) MINUTES. THE PATIENT OUTCOME WAS REPORTED AS STABLE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X16MM 3.5 AND 4.0. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019148 ↗
• MalfunctionDec 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DURING A CERVICAL SPINE SURGERY WITH SYMP C2-TH2 THE CREW REF # 1020-35-116S LOT # 307527 COULD NOT BE PICKED UP ORTHOGRADE WITH THE SCREWDRIVER SHAFT (REF # 202033400 LOT # (B)(4) AND SLEEVE (REF # 202000401 LOT # (B)(4)) FROM THE STERILE TUBE. THE SCREW HAD TO BE TAKEN OUT OF THE TUBE MANUALLY. BUT EVEN AFTER THIS, SEVERAL ATTEMPTS WERE MADE TO RECORD THE SCREW ORTHOGRADELY. ONLY A 100% CORRECT PICK-UP ENABLES THE SCREW TO BE SCREWED IN ORTHOGRADELY. THEREFORE, INSERTION WITH THE RATCHET HANDLE (REF # 202000501) WAS ALSO NOT POSSIBLE, BECAUSE THE USE OF THE RATCHET HANDLE REQUIRES 100% CONNECTION OF THE SCREW WITH THE SCREWDRIVER SHAFT. SURGERY DELAY: 30MIN. SURGERY COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT HARM OR CONSEQUENCES. NO ALLEGATION AGAINST THE MENTIONED INSTRUMENTS: SCREWDRIVER SHAFT (REF # 202033400 LOT # (B)(4)) NOT AVAILABLE FOR RETURN. SLEEVE (REF # 202000401 LOT # (B)(4)) NOT AVAILABLE FOR RETURN. RATCHET HANDLE (REF # 202000501) NOT AVAILABLE FOR RETURN. CONCOMITANT DEVICE REPORTED: POLY SCREW DRIVER SHFT X20 (PART# 202033400, LOT# (B)(4), QUANTITY UNKNOWN). POLY SCREW DRIVER RETEN SLEEVE (PART# 202000401, LOT# (B)(4), QUANTITY UNKNOWN) AO HANDLE MEDIUM W RATCHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961682 ↗