NA 03.614.027Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034714981), received between Jun 11, 2021 and May 17, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2025Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THE PERSUADER WAS DIFFICULT TO ASSEMBLE. WEAR AND TEAR WAS NOTICED; THE METAL WAS NOT ALIGNING. ANOTHER SET WAS OPENED. THERE WAS NO SURGICAL DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041092 ↗
• MalfunctionSep 20, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PRONGS ON THE PERSUADER WERE SPLAYED TOO FAR APART AND COULD NOT GRASP THE SCREW HEADS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20266726 ↗
• MalfunctionNov 29, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ISRAEL AS FOLLOWS: IT WAS REPORTED ON NOVEMBER 6, 2023, THAT DURING A POSTERIOR CERVICAL SURGERY WITH "SYNAPS" SET THE THREE ITEMS DID NOT WORK PROPERLY EVEN THOUGH THE SURGEON FOLLOWED THE TECHNIQUE CORRECTLY. SKU ROD INTRODUCT-NSTR DISINTEGRATED SEVERAL TIMES DURING USE. SKU HOLD-SL FAILED TO CONNECT TO THE SCREW PROPERLY AND IT APPEARS TO BE WORN AT ITS END. SKU BEND-PLIER F/R 3.5 IT WAS NOT POSSIBLE TO BEND THE ROD AS EXPECTED ACCORDING TO THE SURGEON. THERE WAS NO UNUSUAL USE OF THE PRODUCT AND THESE ARE PRODUCTS THAT BELONG TO A SET THAT THE SURGEON HAS BEEN USING FOR YEARS IN THIS HOSPITAL AND IN OTHER HOSPITALS. SKU. HOLD-SL ACCORDING TO WHAT IS VISIBLE, IT APPEARS TO BE DUE TO NATURAL WEAR AND TEAR AND THE OTHER ITEMS HAVE AN UNKNOWN CAUSE. THIS IS A SENIOR SURGEON WHO KNOWS THE TECHNIQUE AND WAS PROPERLY INSTRUCTED. THE SURGEON OVERCAME THE INCIDENT BY USING ADDITIONAL PRODUCTS IN THE SET. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1)ROD INTRODUCT-NSTR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231688 ↗
• MalfunctionOct 4, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SET WAS OPEN PRIOR TO THE CASE START, AND THE PERSUADER INSTRUMENT HAD FALLEN APART. THE SCREW THAT HOLDS THE SPRING MECHANISM OF THE INSTRUMENT HAD FALLEN OUT, AND THE SPRING MECHANISM FELL APART. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE PERSUADER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17870015 ↗
• InjuryJul 10, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THAT THE DURING A POSTERIOR CERVICAL FIXATION USING SYNAPSE SYSTEM, THE SURGEON REQUESTED TO USE THE REDUCTION DEVICE. THE SCRUB HANDED THE INSTRUMENT TO THE SURGEON IN THE HORIZONTAL PLANE, THE SURGEON USED THE DEVICE AND AS HE LISTED IT OFF THE SCREW THE INNER BARREL FELL AND HIT THE EXPOSED SPINAL CORD, CAUSING THE PATIENT TO HAVE FURTHER INJURY. PATIENT STATUS/ OUTCOME : OPERATION COMPLETED, PATIENT REMAINED SEDATED AND IN ITU. THIS REPORT IS FOR ONE (1) ROD INTRODUCT-NSTR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Spinal Cord Injury

  MAUDE report 17287514 ↗
• MalfunctionFeb 13, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE CLIP¿S ATTACHMENT TO THE SLEEVES WAS NOT TIGHT ENOUGH. DURING ROD REDUCTION, THEY SLIPPED AND LOST THEIR ATTACHMENT ON THE SLEEVE AND THE SCREW HEAD. THEREFORE IT¿S NOT DOING ITS WORK ACCORDING TO ITS PURPOSE OF PRESSING THE ROD DOWN. THERE WAS A 15 MINUTE DELAY IN SURGERY AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR PRODUCT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE PERSUADER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16367904 ↗
• MalfunctionOct 31, 2022Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DUE TO OVERUSE AND WEAR AND TEAR THE PERSUADER FROM THE SYNAPSE SET ISN'T REDUCING THE ROD CORRECTLY AS THE INNER SLEEVE GETS STUCK. ALSO THE OUTTER SLEEVE DOESN'T CORRECTLY ENGAGE WITH THE SCREW HEAD AS ITS LOOSE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADDITIONAL TIME NEEDED IN THE SURGERY. NO OTHER INFO IS AVAILABLE. IS UNKNOWN IF THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1) PERSUADER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700623 ↗
• MalfunctionOct 27, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE INSTRUMENT WAS LOOSE AND SLACK, ATTACHES POORLY TO THE SCREW. IT SLIPS QUICKLY AND IS UNSTABLE. PROCEDURE WAS DELAYED FOR FIFTEEN(15)- TWENTY(20) MINUTES. THIS REPORT IS FOR ONE (1) PERSUADER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704975 ↗
• MalfunctionJun 11, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE INSTRUMENT HANDLE WAS DISENGAGED FROM THE INNER AND OUT SHAFTS. THE SHAFTS ARE REMAINED ATTACHED TO THE PLOY AXIAL SCREW HEAD AND THE HANDLE COULD NOT BE REATTACHED. THE SURGERY WAS DELAYED TWO-MINUTES. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS: SYNAPSE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). UNKNOWN POLYAXIAL SCREWS: SYNAPSE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) ROD INTRODUCT-NSTR. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988011 ↗