NA 03.825.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10705034732022), received between Dec 21, 2016 and Jan 27, 2021 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE SYNFIX EVOLUTION TRIAL MEDIUM 15MM WOULD NOT DISENGAGE FROM THE EVOLUTION SPINDLE. THE TRIAL WOULD UNWIND TO DISENGAGE THE KNOB, BUT THE LONG SHAFT WAS STUCK AT THE THREADED PORTION OF THE SPINDLE. THERE WAS NO REPORTED SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: SYNFIX EVOL TRIAL IMPLANT HOLDER (PART NUMBER 03.835.100, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) SPINDLE FOR EVOLUTION. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11236044 ↗
• MalfunctionOct 27, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS MALDEN, MA SITE, IT WAS OBSERVED THAT A SPINDLE FOR EVOLUTION WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPINDLE FOR EVOLUTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10741177 ↗
• MalfunctionSep 30, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 AFTER THE SURGERY THE HANDLE OF THE HAMMER WAS DISCOVERED TO BE LOOSE AND WOBBLY. THIS REPORT IS FOR ONE (1) SPINDLE FOR EVOLUTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10605881 ↗
• MalfunctionJul 29, 2020Break; Break

  CONCOMITANT DEVICE REPORTED: SYNFIX EVOLUTION TRIAL IMPL SM H12 10° (PART # 03.835.112, LOT# L880633, QUANTITY 1). SYNFIX EVOL TRIAL IMPLANT HOLDER (PART # 03.835.110, LOT# H236313, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10338395 ↗
• MalfunctionApr 2, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN ANTERIOR LEVEL INTERBODY FUSION (ALIF) WAS CONDUCTED; THE DR AT (B)(6) - THE PATIENT HAD A TWO LEVEL ANTERIOR LEVEL INTERBODY FUSION (ALIF) OPERATION AT LEVELS L3/4 AND L4/5. THE CASE WENT SMOOTHLY. AFTER THE CASE WAS FINISHED, THE SCRUB NURSE WAS PUTTING THE INSTRUMENTS BACK IN THE TRAYS AND WHEN SHE WENT TO DISENGAGE THE SPINDLE FROM THE TRIAL HOLDER BY TURNING THE TOP OF THE SPINDLE, THE "KNOB"/ TOP OF THE SPINDLE SHAFT, CAME OFF THE SPINDLE. THE SHAFT OF THE SPINDLE WAS THEN STILL ENGAGED INSIDE THE TRIAL IMPLANT HOLDER AND STILL ATTACHED TO THE TRIAL. THIS COULD ONLY BE UNDONE/RELEASED BY APPLYING A PAIR OF MULTIGRIP PLIERS TO THE TOP OF THE SPINDLE SHAFT. NO AE TO PATIENT. (THIS OCCURRED AFTER THE OPERATION WAS FINISHED SO THERE WAS NO DELAY) . THERE IS ALSO A SECOND SET OF SPINDLE AND TRIAL HOLDER HANDLE ON THE SET. CONCOMITANT DEVICE REPORTED: UNKNOWN TRIAL IMPLANT HOLDER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9918864 ↗
• MalfunctionMar 25, 2020Break; Break

  IT WAS REPORTED THAT ON FEBRUARY 28, 2020, A SPINDLE FOR EVOLUTION HAS BROKEN WELD. ISSUE WAS FOUND AT LOANERS DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9879035 ↗
• MalfunctionMar 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE SPINDLE OR TRIAL INSERTER BECAME LOOSE AND COULDN¿T BE REMOVED POST PROCEDURE WHEN PACKING UP SET. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 1 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9862632 ↗
• MalfunctionFeb 19, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN INCOMING INSPECTION OF A LOANER SET, THE SPINDLE WAS DISCOVERED AS BROKEN. NO INFORMATION ABOUT THE EVENT OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPINDLE FOR EVOLUTION THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9727623 ↗
• MalfunctionFeb 7, 2020Break; Break

  UPDATED EVENT DESCRIPTION CONCOMITANT DEVICE REPORTED: UNK - CAGE/SPACERS: SYNCAGE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9682845 ↗
• MalfunctionFeb 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SURGEON WAS USED TRAILED IMPLANT BUT THE SYNFIX EVOLUTION TRIAL MEDIUM HEIGHT WOULD NOT COME OFF THE TRIAL IMPLANT HOLDER. WHEN THE NURSE WAS TRYING TO DISENGAGE THE TRIAL FROM THE EVOLUTION SPINDLE THAT GOES DOWN THE TRIAL IMPLANT HOLDER TO ENGAGE THE TRAIL WOULD UNWIND TO DISENGAGE THE KNOB HOWEVER THE LONG SHAFT WAS STUCK AT THE THREADED PORTION OF THE SPINDLE. THE IMPLANT TRIAL IS STUCK ONTO THE IMPLANT HOLDER (2-PIECE INSTRUMENT) IN SIMPLER TERMS. IT COULD NOT DISENGAGE THE TRIAL FROM THE TRIAL HOLDER. THERE WAS 30 MINUTES DELAY OF SURGERY AND COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS IS THE REPORT OF (1) SYNCAGE EVOLUTION SPINDLE. THIS IS REPORT 02 OF 03 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9671160 ↗
• MalfunctionJan 16, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING INSPECTION OF DEVICES AT THE STORAGE FACILITY THE WELDING SEAM FROM HEAD TO SHAFT IS BROKEN OFF TWO (2) SYNCAGE SPINDLE INSTRUMENTS. THE HEAD CAN NOW BE MOVED AND TURNED WHICH LEAVES THE DEVICES NONFUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9595703 ↗
• MalfunctionJan 16, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING INSPECTION OF DEVICES AT THE STORAGE FACILITY THE WELDING SEAM FROM HEAD TO SHAFT IS BROKEN OFF TWO (2) SYNCAGE SPINDLE INSTRUMENTS. THE HEAD CAN NOW BE MOVED AND TURNED WHICH LEAVES THE DEVICES NONFUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9595689 ↗
• MalfunctionDec 9, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, AT THE END OF THE CASE, I WAS PACKING UP THE SET AND THE SYNFIX EVOLUTION TRIAL M 13.5 10 DEGREE WOULD NOT COME OFF THE TRIAL IMPLANT HOLDER. WHEN I WAS TRYING TO DISENGAGE THE TRIAL THE EVOLUTION SPINDLE THAT GOES DOWN THE TRIAL IMPLANT HOLDER TO ENGAGE THE TRAIL WOULD UNWIND TO DISENGAGE THE KNOB. HOWEVER, THE LONG SHAFT WAS STUCK AT THE THREADER PORTION OF THE SPINDLE. THE IMPLANT TRIAL IS STUCK ONTO THE IMPLANT HOLDER (2 PIECES INSTRUMENT) IN SIMPLER TERMS. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437318 ↗
• MalfunctionOct 31, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE A SPINDLE FOR EVOLUTION INSTRUMENT WAS NOT FUNCTIONING PROPERLY. WHEN THE INSTRUMENT IS DISENGAGED FROM THE TRIAL SPACER THE DEVICE LEAVES THE HEAD SCREWS ATTACHED TO THE TRIAL. THE INSTRUMENT IS FROM A SYNFIX LOANER SET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE BACK UP DEVICE IN THE SET. NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN TRIAL SPACER (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9262087 ↗
• MalfunctionOct 16, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE KNOB OF THE SYNCAGE EVOLUTION SPINDLE HAS UNSCREWED FROM THE SHAFT. WHEN THE KNOB IS TURNED IT UNSCREWS FROM THE SHAFT AND THE SPINDLE CANNOT RELEASE THE TRIAL. AN ADDITIONAL SPINDLE WAS USED TO COMPLETE THE SURGERY WITHOUT PATIENT CONSEQUENCE. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN TRIAL SPACER, (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). UNKNOWN EVOLUTION IMPLANT HOLDER, (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SYNCAGE EVOLUTION SPINDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198463 ↗
• MalfunctionAug 20, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE KNOB OF THE SYNCAGE EVOLUTION SPINDLE CAME UNSCREWED FROM THE SHAFT. THIS MEANT THAT THE SPINDLE COULD NOT BE RELEASE THE TRIAL SPACER AS WHEN THE WAS TURNED, IT UNSCREWED FROM THE SHAFT INSTEAD OF TURNING THE SHAFT TO RELEASE THE TRIAL SPACER. THE INSTRUMENT WAS TAGGED AND PLACED BACK INTO THE SYNCAGE EVOLUTION TRAY TO BE WASHED AND RETURNED WITH THE KIT TO THE WAREHOUSE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO DETRIMENTAL OUTCOME TO THE PATIENT AS THERE IS A SECOND SPINDLE ON THE KIT. CONCOMITANT DEVICES: TRIAL SPACER (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A SPINDLE FOR EVOLUTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8912212 ↗
• MalfunctionJun 11, 2019Break; Mechanical Problem; Material Integrity Problem; Unintended Movement; Break; Mechanical Problem; Material Integrity Problem; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ON AN UNKNOWN PROCEDURE, WHILE MALLETING INSERTER, THE SPINDLE FOR EVOLUTION UNTHREADED AT THE WELD. THEY USED ANOTHER SPINDLE FOR EVOLUTION AND WAS PULLED OUT IN THE SAME TRAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO ADVERSE PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN MALLET/HAMMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SPINDLE FOR EVOLUTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8687036 ↗
• MalfunctionApr 4, 2019Material Deformation; Material Deformation

  IT WAS REPORTED ON THAT ON AN UNKNOWN DATE, THE SPINDLE FOR EVOLUTION WAS FOUND TO HAVE A CRACKED WELD. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPINDLE FOR EVOLUTION THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8482723 ↗
• MalfunctionFeb 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, A SYNCAGE EVOLUTION SPINDLE WAS NOTICED TO STUCK TO THE UNKNOWN TRIAL IMPLANT INTENDED TO BE USED IN A SPINE PROCEDURE WHEN THE SET WAS PICKED UP. IT WAS DISCOVERED ON INSPECTION AFTER THE SURGERY. THE STERILIZATION STAFF COULD NOT GET THE TWO PARTS APART. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPINDLE FOR EVOLUTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8377809 ↗
• MalfunctionJan 28, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, DURING INSPECTION, THE TECHNICIAN FOUND THE HEAD OF THE SYNCAGE EVOLUTION SPINDLE IMPLANT HOLDER WAS UNCOUPLED FROM THE STEM. THIS WAS DISCOVERED BY UNSCREWING ABNORMALLY. THERE WERE NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPINDLE FOR EVOLUTION THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8281630 ↗
• MalfunctionDec 31, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A SPINAL PROCEDURE OF AN INTERNAL STEM EXTREMITY OF THE TWO (2) TRIAL IMPLANT HOLDER SYNFIX / SYNCAGE EVOLUTION SPINDLE WERE UNSCREWED SO IT WAS HARD TO REMOVE AN UNKNOWN TRIAL IMPLANT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS ANY SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE: TRIAL IMPLANT (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SPINDLE FOR EVOLUTION. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8206670 ↗
• MalfunctionDec 31, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A SPINAL PROCEDURE OF AN INTERNAL STEM EXTREMITY OF THE TWO (2) TRIAL IMPLANT HOLDER SYNFIX / SYNCAGE EVOLUTION SPINDLE WERE UNSCREWED SO IT WAS HARD TO REMOVE AN UNKNOWN TRIAL IMPLANT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS ANY SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE: TRIAL IMPLANT (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SPINDLE FOR EVOLUTION. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8206649 ↗
• MalfunctionNov 14, 2018Break; Break

  IT WAS REPORTED THAT AFTER AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE AT L4-L5 ON (B)(6) 2018, IT WAS NOTED THAT THE WELD BETWEEN THE STEM AND THE HANDLE ON THE SPINDLE FOR EVOLUTION WAS BROKEN. ISSUE WAS DISCOVERED DURING DISASSEMBLY OF THE EQUIPMENT AFTER THE PROCEDURE. PROCEDURE WAS COMPLETED WITH NO DELAY AND NO CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8071350 ↗
• MalfunctionNov 13, 2018Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE ON AND ON AN UNKNOWN PROCEDURE TWO (2) SPINDLE FOR EVOLUTION WERE FAULTY WHEN BEING USED. THE SPINDLE FOR EVOLUTION COULD NOT DISCONNECT THE TRIAL FROM THE INSERTER AS THE KNOB DISCONNECTED FROM THE SPINDLE ITSELF EACH TIME. IT IS UNKNOWN IF THERE WERE ANY SURGICAL DELAY OR ADVERSE EVENT TO THE PATIENT. CONCOMITANT DEVICES: SYNFIX EVOLUTION TRIAL SPACER (PART: 03.835.263, LOT: L543726, QUANTITY: 1); SYNFIX EVOLUTION TRIAL IMPLANT HOLDER (PART: 03.835.100, LOT: H326553, QUANTITY: 2); SYNFIX EVOLUTION PROBE IMPLANT (PART: 03.835.364, LOT: L479565, QUANTITY: 1). THIS REPORT IS FOR A SPINDLE FOR EVOLUTION. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8064551 ↗
• MalfunctionNov 8, 2018Break; Break

  IT WAS FURTHER REPORTED THAT THERE WAS NO SURGICAL DELAY AND NO DEVICE PIECES REMAINED IN THE PATIENT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8053356 ↗