SYMPHONY 1020-35-114SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034524375), received between Dec 12, 2022 and Jan 16, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2024Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING A ANTERIOR AND POSTERIOR FUSION OF THE THORACIC SPINE FOR OPLL ON (B)(6) 2023, WHEN THE SURGEON ATTACHED THE SCREW IN QUESTION TO SCREWDRIVER, THE SCREW COULD NOT BE STRAIGHT. HE TRIED SEVERAL TIMES, BUT IT WAS NOT SOLVED, SO A SPARE PRODUCT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 3.5X14 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18520699 ↗
• MalfunctionSep 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR CERVICAL FUSION (C2) FOR FORAMEN MAGNUM STENOSIS ON (B)(6) 2023. AFTER INSERTING THE SCREW INTO THE VERTEBRAE WITH A SCREWDRIVER, THE SURGEON TRIED TO REMOVE THE SCREWDRIVER, BUT IT STUCK TO THE SCREW AND WAS DIFFICULT TO REMOVE. THE PATIENT'S BONE QUALITY WAS RELATIVELY FRAGILE, AND THE SCREWDRIVER GOT STUCK UNDER THE CIRCUMSTANCE WHERE STRONG FORCE COULD NOT BE APPLIED TO THE SCREW DURING REMOVAL OF THE SCREWDRIVER. ALTHOUGH THE SCREW WAS INSERTED ONCE, IT WAS ULTIMATELY REMOVED BECAUSE IT COULD NOT PROVIDE THE EXPECTED TORQUE TO THE PATIENT'S RELATIVELY FRAGILE BONE. THEREFORE, A HOOK WAS USED AS A SUBSTITUTE, AND THE EVENT DID NOT AFFECT THE FINAL FIXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS/OUTCOME: STABLE NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - SCREWDRIVERS: SYMPHONY (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) 4.0 PLY SCRW 3.5X14 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787607 ↗
• InjuryDec 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION (C3) FOR THE VERTICAL SUBLUXATION ON (B)(6) 2022. AFTER INSERTION OF THE LATERAL SCREW AT RIGHT C3, THE SURGEON TRIED TO CHANGE DIRECTION OF THE SCREWHEAD WITH THE ADJUSTER, BUT THE SCREWHEAD DID NOT MOVE. THERE WAS A POSSIBILITY THAT THE SCREW HIT THE BONE BECAUSE THE SCREW INSERTION WAS TOO DEEP. ALTHOUGH THE SURGEON FLOATED THE SCREW SLIGHTLY IN REVERSE, THE SCREWHEAD DID NOT MOVE. WHEN THE SURGEON TURNED THE SCREW BACKWARDS WITH THE ADJUSTER, THE SCREW STARTED TO COME OUT. AFTER REMOVING THE SCREW, THE SURGEON CHECKED THE SCREW, AND THE SCREWHEAD WAS STUCK AND DID NOT MOVE AT ALL. THE SCREW HOLE WAS WIDENED BECAUSE OF REMOVING THE SCREW WITH THE ADJUSTER, SO A LARGER SIZE SCREW WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY. INADEQUATE INSTALLATION OF THE SCREWDRIVER WAS SUSPECTED. THE SCREWDRIVER TIP MIGHT HAVE NOT BEEN FIRMLY ATTACHED IN THE SCREW CORE. THE PATIENT STATUS WAS REPORTED AS STABLE. THIS REPORT IS FOR A SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15961337 ↗