NA 04.615.330Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034740423), received between Feb 22, 2018 and Oct 22, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OF A POSTERIOR CERVICAL FUSION WITH THE SYNAPSE 4.0 SYSTEM. IT WAS A RIGHT C1 SCREW AND WAS ORIGINAL PLACED ON (B)(6) 2019. UPON ADMISSION IT WAS DISCOVERED THAT THE C1 SCREW WAS FRACTURED AND THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN SCREW AT RIGHT C1 DUE TO IT BEING RECESSED UNDER THE CORTICAL BONE. PATIENT OUTCOME AND STATUS IS UNKNOWN. THIS COMPLAINT IS LINKED TO (B)(4). CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) 3.5MM TI CORTEX POLYAXIAL SHAFT SCREW 30MM FOR 4.0MM ROD. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9219762 ↗
• InjuryFeb 22, 2018Break; Break

  CONCOMITANT DEVICES REPORTED: SYNAPSE SCREW (C2) (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 2), 4.0MM/6.0MM TITANIUM HARD ROD 120MM/175MM (PART # 04.615.512, LOT # UNKNOWN, QUANTITY # 2), TITANIUM LOCKING SCREW (PART # 04.614.508, LOT # UNKNOWN, QUANTITY # 4), 3.5MM TITANIUM CORTEX POLYAXIAL SHAFT SCREW 30MM FOR/4.0MM RODS (RIGHT C1) (PART # 04.615.330, LOT # UNKNOWN, QUANTITY # 1).

  Patient problems: Foreign Body In Patient; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7289620 ↗
• InjuryFeb 22, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT WITH A C1-C6 SYNAPSE 4.0 MM ROD CONSTRUCT PRESENTED TO THE SURGEON WITH PAIN, AND WAS FOUND TO HAVE A NONUNION AT C1-C2 AND THAT THE RIGHT C1 LOCKING SCREW (04.614.508) HAS COME COMPLETELY OUT OF THE RIGHT C1 SCREW (UNKNOWN SIZE AND PART #). THE ROD PART # IS ALSO UNKNOWN. THE HARDWARE WAS POSSIBLY ORIGINALLY IMPLANTED ON AN UNKNOWN DATE IN 2013. THE SURGEON PLANS TO PERFORM A REVISION ON THE PATIENT IN THE NEAR FUTURE. HE PLANS TO TAKE OUT THE C1 SCREWS AND CUT THE RODS JUST CRANIAL TO THE C2 SCREWS. THE SURGEON DOES NOT INTEND TO REPLACE THE REMOVED HARDWARE WITH OTHER INSTRUMENTATION. THERE ARE SIX DEVICES INVOLVED IN THIS COMPLAINT. THE REVISION FOR THE COMPLAINT REPORTED PREVIOUSLY TOOK PLACE (B)(6) 2018. THE PATIENT HAD A PREVIOUS SURGERY WHERE SYNAPSE 4.0 MM ROD SYSTEM WAS USED ON A POSTERIOR CERVICAL. THE CONSTRUCT WAS FROM C1-C5 WITH SYNAPSE 4.0 (NO SCREWS AT C2). THE PATIENT NEVER HEALED AT THE C1-C2 LEVEL AND THE SURGEON DETERMINED THAT THE PATIENT HAS A NONUNION THERE. AT AN UNKNOWN POINT IN TIME, THE HARDWARE AT C1 FAILED. ON THE LEFT, THE C1 SCREW BROKE OFF INTO THE PATIENTS LATERAL MASS, JUST DISTAL TO THE SYNAPSE SHAFT ON THE SHAFT SCR

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 7289328 ↗
• InjuryFeb 22, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT WITH A C1-C6 SYNAPSE 4.0MM ROD CONSTRUCT PRESENTED TO THE SURGEON WITH PAIN, AND WAS FOUND TO HAVE A NONUNION AT C1-C2 AND THAT THE RIGHT C1 LOCKING SCREW (04.614.508) HAS COME COMPLETELY OUT OF THE RIGHT C1 SCREW (UNKNOWN SIZE AND PART #). THE ROD PART # IS ALSO UNKNOWN. THE HARDWARE WAS POSSIBLY ORIGINALLY IMPLANTED ON AN UNKNOWN DATE IN 2013. THE SURGEON PLANS TO PERFORM A REVISION ON THE PATIENT IN THE NEAR FUTURE. HE PLANS TO TAKE OUT THE C1 SCREWS AND CUT THE RODS JUST CRANIAL TO THE C2 SCREWS. THE SURGEON DOES NOT INTEND TO REPLACE THE REMOVED HARDWARE WITH OTHER INSTRUMENTATION. THERE ARE SIX DEVICES INVOLVED IN THIS COMPLAINT. THE REVISION FOR THE COMPLAINT REPORTED PREVIOUSLY TOOK PLACE (B)(6) 2018. THE PATIENT HAD A PREVIOUS SURGERY WHERE SYNAPSE 4.0MM ROD SYSTEM WAS USED ON A POSTERIOR CERVICAL. THE CONSTRUCT WAS FROM C1-C5 WITH SYNAPSE 4.0 (NO SCREWS AT C2). THE PATIENT NEVER HEALED AT THE C1-C2 LEVEL AND THE SURGEON DETERMINED THAT THE PATIENT HAS A NONUNION THERE. AT AN UNKNOWN POINT IN TIME, THE HARDWARE AT C1 FAILED. ON THE LEFT, THE C1 SCREW BROKE OFF INTO THE PATIENTS LATERAL MASS, JUST DISTAL TO THE SYNAPSE SHAFT ON THE SHAFT SCREW

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 7289317 ↗