NA 04.613.516Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705034737645), received between Apr 13, 2018 and Dec 28, 2023 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN ANTERIOR CERVICAL FUSION (C3-5) WAS PERFORMED ON (B)(6) 2023 FOR OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT. THE SCREWS IN QUESTION WERE INSTALLED, BUT THE TWO BLOCKING CLIPS DID NOT LOCK AS USUAL. SINCE THERE WERE NO PLATES OF THE SAME SIZE AND REPLACING ALL THE SCREWS WOULD BE A MAJOR TASK, ONLY TWO SCREWS IN THE PROBLEM AREA WERE REPLACED WITH NEW ONES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409002 ↗
• InjuryDec 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION FOR OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THERE WAS NO PROBLEM ON INSPECTION IN (B)(6) 2022. THE SCREWS IN QUESTION ARE CURRENTLY LOOSE. ALSO, THE PLATE IN QUESTION IS FLOATING A FEW MILLIMETERS FORWARD FROM THE VERTEBRAE. THE PATIENT IS SCHEDULED FOR REMOVAL AND RE-FIXATION ON (B)(6) 2023. THE PLATE WILL BE SHORTENED BY 2MM, AND THE SCREW WILL BE INCREASED BY 2MM FROM 16MM TO 18MM. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18290146 ↗
• InjuryDec 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION FOR OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THERE WAS NO PROBLEM ON INSPECTION IN SEPTEMBER 2022. THE SCREWS IN QUESTION ARE CURRENTLY LOOSE. ALSO, THE PLATE IN QUESTION IS FLOATING A FEW MILLIMETERS FORWARD FROM THE VERTEBRAE. THE PATIENT IS SCHEDULED FOR REMOVAL AND RE-FIXATION ON (B)(6) 2023. THE PLATE WILL BE SHORTENED BY 2MM, AND THE SCREW WILL BE INCREASED BY 2MM FROM 16MM TO 18MM. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18290141 ↗
• InjuryDec 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION FOR OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THERE WAS NO PROBLEM ON INSPECTION IN SEPTEMBER 2022. THE SCREWS IN QUESTION ARE CURRENTLY LOOSE. ALSO, THE PLATE IN QUESTION IS FLOATING A FEW MILLIMETERS FORWARD FROM THE VERTEBRAE. THE PATIENT IS SCHEDULED FOR REMOVAL AND RE-FIXATION ON (B)(6) 2023. THE PLATE WILL BE SHORTENED BY 2MM, AND THE SCREW WILL BE INCREASED BY 2MM FROM 16MM TO 18MM. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18290139 ↗
• InjuryDec 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION FOR OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THERE WAS NO PROBLEM ON INSPECTION IN (B)(6) 2022. THE SCREWS IN QUESTION ARE CURRENTLY LOOSE. ALSO, THE PLATE IN QUESTION IS FLOATING A FEW MILLIMETERS FORWARD FROM THE VERTEBRAE. THE PATIENT IS SCHEDULED FOR REMOVAL AND RE-FIXATION ON (B)(6), 2023. THE PLATE WILL BE SHORTENED BY 2MM, AND THE SCREW WILL BE INCREASED BY 2MM FROM 16MM TO 18MM. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18290137 ↗
• MalfunctionOct 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT HAD A SCREW BACKING OUT OF A PLATE POSTOPERATIVELY AFTER AN ANTERIOR CERVICAL FUSION. THERE WERE NO PATIENT CONSEQUENCES. THE CERVICAL SCREW REMAINS IN THE PATIENT. THIS REPORT INVOLVES ONE 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17906612 ↗
• MalfunctionDec 13, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2022, WHEN IMPLANTING A VECTRA-PL 4/4.5 1 SEGMENT L33 (04.613.024S), THE SURGEON COULD NOT GET THE CERVIC-SPINE-SCR Ø4 DYNAM (04.613.516S) OUT, LEADING TO THEM NEEDING TO OPEN AN EXTRA PLATE AND SCREW. THIS LED TO A 5 MINUTE DELAY BUT NO EFFECT TO THE PATIENT, AND SURGEON WAS HAPPY WITH THE OUTCOME. NO OTHER MEDICAL INTERVENTION WAS REQUIRED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE DOING WELL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968537 ↗
• MalfunctionOct 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2020, THE 16MM VECTRA SCREW WENT THROUGH A 45MM VECTRA T PLATE SCREW HOLE, AND THE CLIP BROKE INTRAOPERATIVELY. FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10670938 ↗
• MalfunctionOct 30, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION PROCEDURE. DURING THE PROCEDURE, A VECTRA SCREWDRIVER BROKE LIVING A PIECE OF THE DRIVER INSIDE A TITANIUM VARIABLE-ANGLE SCREW. THE DRIVER BROKE WHILE INSERTING THE SCREW. THE PLATE AND THE SCREW WERE REMOVED AND REPLACED. THE SURGEON FELT LIKE THE SCREW WAS ANGLED TOO MUCH AND DECIDED TO REDIRECT THE SCREW. ONCE THE TIP BROKE OFF INSIDE THE SCREW THERE IS NO WAY TO USE THE SETS REMOVAL DRIVER. THE ENTIRE PLATE HAD TO BE BACKED OUT FOR THIS REASON. NO PIECE WAS LEFT IN THE PATIENT. A NEW PLATE AND SCREWS WERE IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIVE (5) MINUTES SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. THIS IS 3 OF 3 FOR REPORT (B)(4).

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

  MAUDE report 9256043 ↗
• InjuryOct 2, 2019Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TOP TITANIUM VARIABLE ANGLE SCREW ON A TWO (2) LEVEL TITANIUM VECTRA ONE PLATE WAS PARTIALLY PULLED OUT. THIS WAS DISCOVERED ON A SIX (6) WEEK POST-OP X-RAY AFTER THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION PROCEDURE ON (B)(6) 2019. THERE WAS NO DEFICIENCY, ALLEGATION, MALFUNCTION AGAINST THE TWO (2) LEVEL PLATE OTHER THAN THE CLIP DID NOT KEEP THE TOP SCREW LOCKED IN. THERE WAS NO PLAN OF REMOVING THE DEVICE. PROCEDURE OUTCOME IS UNKNOWN. PATIENT IS CLINICALLY FINE. CONCOMITANT DEVICE: UNKNOWN SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 4.0 MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16 MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9145569 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A CERVICAL VECTRA PLATE. ON AN UNKNOWN DATE IN 2018, THE PATIENT THEN BEGAN TO EXPERIENCE UNSPECIFIED ALLERGIC SYMPTOMS. THE PATIENT FELT IT WAS DUE TO A NICKEL SENSITIVITY OR ALLERGY. THIS REPORT IS FOR ONE (1) 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7926291 ↗
• InjuryApr 13, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT A 3-LEVEL ANTERIOR CERVICAL INTERBODY FUSION (ACIF) FROM THE C4-C7 LEVELS ON (B)(6) 2017 USING THE SYNTHES VECTRA PLATING SYSTEM, TWO LEVELS OF 7MM LORDOTIC CORTICO-CANCELLOUS ANTERIOR CERVICAL FUSION (CC ACF) FROZEN ALLOGRAFT, AND ONE LEVEL OF 8MM LORDOTIC CC-ACF FROZEN ALLOGRAFT. AFTER THE INTERBODY FUSIONS WERE COMPLETE, A 3-LEVEL VECTRA PLATE (48MM) WAS IMPLANTED ALONG WITH SEVEN (7) 4.0MM X 16 UNKNOWN SCREWS AND ONE (1) 4.5MM X 16 UNKNOWN SCREW. PRIOR TO CLOSING, THE SURGEON VERIFIED THAT ALL IMPLANTS WERE PROPERLY PLACED AND ALL OF THE SCREWS WERE PROPERLY LOCKED INTO THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY AND NO ADVERSE EVENTS WERE REPORTED AGAINST THE PATIENT. POSTOPERATIVELY, ON AN UNKNOWN DATE, X-RAYS WERE TAKEN AND IT WAS IDENTIFIED THAT THE LOWEST TWO (2) OF THE IMPLANTED SCREWS AT C7 HAD BACKED OUT OF THE PLATE BY APPROXIMATELY 3MM. ON (B)(6) 2018, THE PATIENT WAS RETURNED TO THE OPERATING ROOM. DURING THE PROCEDURE, THE VECTRA PLATE AND ALL EIGHT (8) SCREWS WERE EXPLANTED. SEVERAL OF THE OTHER SCREWS WERE NOTED TO BE LOOSE; HOWEVER, THEY WERE STILL LOCKED INTO THE PLATE. AFTER REMOVING THE IMPLANTED DEVICES, THE PATI

  Patient problems: Failure of Implant

  MAUDE report 7431152 ↗
• InjuryApr 13, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT A 3-LEVEL ANTERIOR CERVICAL INTERBODY FUSION (ACIF) FROM THE C4-C7 LEVELS ON (B)(6) 2017 USING THE SYNTHES VECTRA PLATING SYSTEM, TWO LEVELS OF 7MM LORDOTIC CORTICO-CANCELLOUS ANTERIOR CERVICAL FUSION (CC ACF) FROZEN ALLOGRAFT, AND ONE LEVEL OF 8MM LORDOTIC CC-ACF FROZEN ALLOGRAFT. AFTER THE INTERBODY FUSIONS WERE COMPLETE, A 3-LEVEL VECTRA PLATE (48MM) WAS IMPLANTED ALONG WITH SEVEN (7) 4.0MM X 16 UNKNOWN SCREWS AND ONE (1) 4.5MM X 16 UNKNOWN SCREW. PRIOR TO CLOSING, THE SURGEON VERIFIED THAT ALL IMPLANTS WERE PROPERLY PLACED AND ALL OF THE SCREWS WERE PROPERLY LOCKED INTO THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY AND NO ADVERSE EVENTS WERE REPORTED AGAINST THE PATIENT. POSTOPERATIVELY, ON AN UNKNOWN DATE, X-RAYS WERE TAKEN AND IT WAS IDENTIFIED THAT THE LOWEST TWO (2) OF THE IMPLANTED SCREWS AT C7 HAD BACKED OUT OF THE PLATE BY APPROXIMATELY 3MM. ON (B)(6) 2018, THE PATIENT WAS RETURNED TO THE OPERATING ROOM. DURING THE PROCEDURE, THE VECTRA PLATE AND ALL EIGHT (8) SCREWS WERE EXPLANTED. SEVERAL OF THE OTHER SCREWS WERE NOTED TO BE LOOSE; HOWEVER, THEY WERE STILL LOCKED INTO THE PLATE. AFTER REMOVING THE IMPLANTED DEVICES, THE PATI

  Patient problems: Failure of Implant

  MAUDE report 7431113 ↗