NA 498.957Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034792316), received between Mar 3, 2017 and Nov 15, 2021 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2021Material Integrity Problem; No Apparent Adverse Event; Material Integrity Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2021, ONE 3.5MM TITANIUM ROD AND ONE 3.5MM TITANIUM CURVED ROD WAS FOUND TO BE BROKEN DURING THE REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM TI ROD 240MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12811265 ↗
• MalfunctionJun 17, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED ON (B)(6) 2020 THAT TWO (2) TITANIUM RODS AND ONE (1) TITANIUM CURVED ROD WERE BROKEN DURING A REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 240MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10164990 ↗
• MalfunctionJun 17, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED ON (B)(6) 2020 THAT ON UNKNOWN DATE, TWO (2) 3.5MM TITANIUM CURVED RODS AND ONE (1) 3.5MM TITANIUM ROD WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 240MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10163361 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) 240MM TITANIUM (TI) ROD, ONE (1) 500MM TITANIUM (TI) ROD, THREE (3) 80MM TITANIUM (TI) CURVED ROD, ONE (1) 500MM TITANIUM (TI) SOFT ROD AND ONE (1) 40MM TITANIUM (TI) CURVED ROD WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10163254 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) 240MM TITANIUM (TI) ROD, ONE (1) 500MM TITANIUM (TI) ROD, THREE (3) 80MM TITANIUM (TI) CURVED ROD, ONE (1) 500MM TITANIUM (TI) SOFT ROD AND ONE (1) 40MM TITANIUM (TI) CURVED ROD WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10162594 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) 240MM TITANIUM (TI) ROD, ONE (1) 500MM TITANIUM (TI) ROD, THREE (3) 80MM TITANIUM (TI) CURVED ROD, ONE (1) 500MM TITANIUM (TI) SOFT ROD AND ONE (1) 40MM TITANIUM (TI) CURVED ROD WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10162394 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR (4) 240MM TITANIUM (TI) ROD, ONE (1) 500MM TITANIUM (TI) ROD, THREE (3) 80MM TITANIUM (TI) CURVED ROD, ONE (1) 500MM TITANIUM (TI) SOFT ROD AND ONE (1) 40MM TITANIUM (TI) CURVED ROD WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10162291 ↗
• MalfunctionJun 16, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE 3 6.0MM TITANIUM SOFT ROD 500MM, 5 3.5MM TITANIUM ROD 240MM, 1 3.5MM TITANIUM CURVED ROD 80MM, AND 1 3.5MM TITANIUM CURVED ROD 40MM WERE FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR 1 3.5MM TI ROD 240MM. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10159976 ↗
• MalfunctionJun 16, 2020Break; Break

  IT WAS REPORTED THAT THE THREE (3) 6.0MM TITANIUM SOFT ROD 500MM, FIVE (5) 3.5MM TITANIUM ROD 240MM, ONE (1) 3.5MM TITANIUM CURVED ROD 80MM, AND ONE (1) 3.5MM TITANIUM CURVED ROD 40MM WERE FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 240MM. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10159974 ↗
• MalfunctionJun 16, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE THREE (3) 6.0MM TITANIUM SOFT ROD 500MM, FIVE (5) 3.5MM TITANIUM ROD 240MM, ONE (1) 3.5MM TITANIUM CURVED ROD 80MM, AND ONE (1) 3.5MM TITANIUM CURVED ROD 40MM WERE FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 240MM. THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10159970 ↗
• MalfunctionJun 16, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE 3 6.0MM TITANIUM SOFT ROD 500MM, 5 3.5MM TITANIUM ROD 240MM, 1 3.5MM TITANIUM CURVED ROD 80MM, AND 1 3.5MM TITANIUM CURVED ROD 40MM WERE FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR 1 3.5MM TI ROD 240MM THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10159966 ↗
• MalfunctionJun 16, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE THREE (3) 6.0MM TITANIUM SOFT ROD 500MM, FIVE (5) 3.5MM TITANIUM ROD 240MM, ONE (1) 3.5MM TITANIUM CURVED ROD 80MM, AND ONE (1) 3.5MM TITANIUM CURVED ROD 40MM WERE FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 240MM. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10159853 ↗
• InjuryNov 6, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT C2-T2 POSTERIOR SPINAL FUSION LAST (B)(6) 2012 WITH SYNTHES 3.5 MM ROD SYSTEM. ON AN UNKNOWN DATE, PATIENT BROKE BOTH RODS CAUDAL TO THE C6 SCREWS. THE PATIENT HAS A NON-UNION AT THE AREA OF THE ROD BREAKAGE. ON (B)(6) 2018, A REVISION WAS PERFORMED. THE SURGEON ELECTED TO REMOVED ALL THE SYNAPSE 3.5MM ROD HARDWARE AND REPLACED IT WITH SYNAPSE 4.0MM ROD SYSTEM HARDWARE. THERE WERE NO OTHER ISSUES WITH THE PREVIOUS SYNAPSE 3.5MM ROD HARDWARE OTHER THAN THE ROD BREAKAGE. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 240MM. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8043889 ↗
• InjuryNov 6, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT C2-T2 POSTERIOR SPINAL FUSION LAST (B)(6) 2012 WITH SYNTHES 3.5 MM ROD SYSTEM. ON AN UNKNOWN DATE, PATIENT BROKE BOTH RODS CAUDAL TO THE C6 SCREWS. THE PATIENT HAS A NON-UNION AT THE AREA OF THE ROD BREAKAGE. ON (B)(6) 2018, A REVISION WAS PERFORMED. THE SURGEON ELECTED TO REMOVED ALL THE SYNAPSE 3.5MM ROD HARDWARE AND REPLACED IT WITH SYNAPSE 4.0MM ROD SYSTEM HARDWARE. THERE WERE NO OTHER ISSUES WITH THE PREVIOUS SYNAPSE 3.5MM ROD HARDWARE OTHER THAN THE ROD BREAKAGE. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 240MM. COMCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(6).

  Patient problems: No Code Available

  MAUDE report 8043820 ↗
• InjuryMar 3, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO HARDWARE MIGRATION. PATIENT HAD AN ANTERIOR CORPECTOMY AT UNKNOWN LEVEL AND POSTERIOR FUSION WITH SYNAPSE AT C4-C6 AND T1-T2 ON (B)(6) 2016 DUE TO SPINAL STENOSIS. PATIENT WAS IMPLANTED WITH AN UNKNOWN PLATE ANTERIORLY. THE FOLLOWING WERE IMPLANTED POSTERIORLY: TWO 3.5MMX240MM TITANIUM (TI) RODS, SIX 3.5MMX12MM TI CANCELLOUS POLYAXIAL SCREWS AT C4-C6, TWO 4.5MMX26MM TI CANCELLOUS POLYAXIAL SCREWS AT T1, TWO 4.5MMX28MM TI CANCELLOUS POLYAXIAL SCREWS AT T2, AND TEN TI LOCKING SCREWS. X-RAYS TAKEN DURING THE SIX WEEKS FOLLOW UP ON UNKNOWN DATE CONFIRMED THAT THE TWO LOCKING SCREWS AT T2 CAME OUT OF THE SCREWS AND WERE FLOATING FREELY. THE TWO RODS AT T2 WERE OUT OF THE SCREWS. IT IS UNKNOWN IF PATIENT REPORTED ANY ADVERSE EVENTS. SURGEON WAS CONCERNED AND INDICATED THAT THE MIGRATION COULD BE CAUSED BY TWO SCENARIOS: EITHER THE RODS WERE NOT LONG ENOUGH OR THE TWO 2NM TORQUE LIMITING HANDLES USED IN THE INITIAL SURGERY MAY NOT HAVE TIGHTENED THE LOCKING SCREWS ALL THE WAY. THERE WERE NO REPORTED ISSUES WITH THE HANDLES DURING THE INITIAL SURGERY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. SURGEON REMOVED AND REPLACED

  Patient problems: Failure of Implant

  MAUDE report 6377059 ↗
• InjuryMar 3, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO HARDWARE MIGRATION. PATIENT HAD AN ANTERIOR CORPECTOMY AT UNKNOWN LEVEL AND POSTERIOR FUSION WITH SYNAPSE AT C4-C6 AND T1-T2 ON (B)(6) 2016 DUE TO SPINAL STENOSIS. PATIENT WAS IMPLANTED WITH AN UNKNOWN PLATE ANTERIORLY. THE FOLLOWING WERE IMPLANTED POSTERIORLY: TWO 3.5MMX240MM TITANIUM (TI) RODS, SIX 3.5MMX12MM TI CANCELLOUS POLYAXIAL SCREWS AT C4-C6, TWO 4.5MMX26MM TI CANCELLOUS POLYAXIAL SCREWS AT T1, TWO 4.5MMX28MM TI CANCELLOUS POLYAXIAL SCREWS AT T2, AND TEN TI LOCKING SCREWS. X-RAYS TAKEN DURING THE SIX WEEKS FOLLOW UP ON UNKNOWN DATE CONFIRMED THAT THE TWO LOCKING SCREWS AT T2 CAME OUT OF THE SCREWS AND WERE FLOATING FREELY. THE TWO RODS AT T2 WERE OUT OF THE SCREWS. IT IS UNKNOWN IF PATIENT REPORTED ANY ADVERSE EVENTS. SURGEON WAS CONCERNED AND INDICATED THAT THE MIGRATION COULD BE CAUSED BY TWO SCENARIOS: EITHER THE RODS WERE NOT LONG ENOUGH OR THE TWO 2NM TORQUE LIMITING HANDLES USED IN THE INITIAL SURGERY MAY NOT HAVE TIGHTENED THE LOCKING SCREWS ALL THE WAY. THERE WERE NO REPORTED ISSUES WITH THE HANDLES DURING THE INITIAL SURGERY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. SURGEON REMOVED AND REPLACED

  Patient problems: Failure of Implant

  MAUDE report 6377040 ↗