NA 04.613.518Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034737669), received between Aug 8, 2018 and Jul 30, 2020 — classified as 8 injuries.

The most frequently reported specific device problem is “Migration” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON ATTEMPTED TO REMOVE AN UNKNOWN VECTRA-T PLATE AND SCREW FROM THE PATIENT. THE REASON FOR REMOVAL OF THE PLATE AND SCREWS WAS DUE TO ADJACENT LEVEL DISC DISEASE. THIS WAS A REVISION ACDF FOR ADJACENT LEVEL DISEASE. BONE WAS ENCASED OVER THE PLATE AND NEEDED TO BE REMOVED. VARIOUS TOOLS WERE UTILIZED TO REMOVE THE BONE INCLUDING BOVIE AND CURETTES. THEY ALSO USED THE SCREW HEAD CLEANING TOOL AND EXTRACTION SCREWDRIVER FROM THE VECTRA-T PLATING SYSTEM. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE. REMOVAL OF THE BROKEN DEVICE AND FRAGMENTS WAS COMPLETED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF THIRTY (30) SECONDS. THE IMPLANTS WERE SUCCESSFULLY REMOVED.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 10347144 ↗
• InjuryMar 5, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION REVISION SURGERY TO REPLACE THE TWO (2) TITANIUM CERVICAL SELF-RETAIN SCREWS SELF-DRILLING/VARIABLE ANGLE 18MM IN THE UNKNOWN PLATE. THE PATIENT CAME TO OFFICE FOR AFTER SURGERY FOLLOW UP WITH ROUTINE X-RAYS. THE SURGEON NOTICED BOTTOM SCREWS OF THE CONSTRUCT WERE PROTRUDING FROM PLATE. THE DATE OF ORIGINAL IMPLANT WAS (B)(6) 2019. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: PLATE (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A TITANIUM CERVICAL SELF-RETAIN SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8390298 ↗
• InjuryMar 5, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL FUSION REVISION SURGERY TO REPLACE THE TWO (2) TITANIUM CERVICAL SELF-RETAIN SCREWS SELF-DRILLING/VARIABLE ANGLE 18MM IN THE UNKNOWN PLATE. THE PATIENT CAME TO OFFICE FOR AFTER SURGERY FOLLOW UP WITH ROUTINE X-RAYS. THE SURGEON NOTICED BOTTOM SCREWS OF THE CONSTRUCT WERE PROTRUDING FROM PLATE. THE DATE OF ORIGINAL IMPLANT WAS (B)(6) 2019. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: PLATE (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A TITANIUM CERVICAL SELF-RETAIN SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8390280 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD AN ALLERGIC REACTION TO DEVICES IMPLANTED AFTER AN UNKNOWN SURGERY. PATIENT HAD ITCHINESS, NEXT PATIENT TURNED RED AND HAD NUMBNESS FROM HIS NECK TO HIS LEFT SHOULDER. THE PATIENT WAS IMPLANTED WITH A TITANIUM VECTRA PLATE AND FOUR (4) TITANIUM SELF-DRILLING SCREWS ON (B)(6) 2015 FOR AN UNKNOWN PROCEDURE. THE PATIENT STATED THAT HE'S ALLERGIC TO NICKEL AND WANTS TO KNOW IF THE IMPLANTS CONTAINED THE MINERAL. THE SYMPTOMS OF RASH OCCURRED ALMOST IMMEDIATELY AFTER SURGERY. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 4.0MM TI CERVICLE SELF-RETAIN SCREW. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Hypoesthesia; Itching Sensation

  MAUDE report 8188485 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD AN ALLERGIC REACTION TO DEVICES IMPLANTED AFTER AN UNKNOWN SURGERY. PATIENT HAD ITCHINESS, NEXT PATIENT TURNED RED AND HAD NUMBNESS FROM HIS NECK TO HIS LEFT SHOULDER. THE PATIENT WAS IMPLANTED WITH A TITANIUM VECTRA PLATE AND FOUR (4) TITANIUM SELF-DRILLING SCREWS ON (B)(6) 2015 FOR AN UNKNOWN PROCEDURE. THE PATIENT STATED THAT HE'S ALLERGIC TO NICKEL AND WANTS TO KNOW IF THE IMPLANTS CONTAINED THE MINERAL. THE SYMPTOMS OF RASH OCCURRED ALMOST IMMEDIATELY AFTER SURGERY. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 4.0MM TI CERVICLE SELF-RETAIN SCREW. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Hypoesthesia; Itching Sensation

  MAUDE report 8188480 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD AN ALLERGIC REACTION TO DEVICES IMPLANTED AFTER AN UNKNOWN SURGERY. PATIENT HAD ITCHINESS, NEXT PATIENT TURNED RED AND HAD NUMBNESS FROM HIS NECK TO HIS LEFT SHOULDER. THE PATIENT WAS IMPLANTED WITH A TITANIUM VECTRA PLATE AND FOUR (4) TITANIUM SELF-DRILLING SCREWS ON (B)(6) 2015 FOR AN UNKNOWN PROCEDURE. THE PATIENT STATED THAT HE'S ALLERGIC TO NICKEL AND WANTS TO KNOW IF THE IMPLANTS CONTAINED THE MINERAL. THE SYMPTOMS OF RASH OCCURRED ALMOST IMMEDIATELY AFTER SURGERY. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 4.0MM TI CERVICLE SELF-RETAIN SCREW. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Hypoesthesia; Itching Sensation

  MAUDE report 8188407 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD AN ALLERGIC REACTION TO DEVICES IMPLANTED AFTER AN UNKNOWN SURGERY. PATIENT HAD ITCHINESS, NEXT PATIENT TURNED RED AND HAD NUMBNESS FROM HIS NECK TO HIS LEFT SHOULDER. THE PATIENT WAS IMPLANTED WITH A TITANIUM VECTRA PLATE AND FOUR (4) TITANIUM SELF-DRILLING SCREWS ON (B)(6) 2015 FOR AN UNKNOWN PROCEDURE. THE PATIENT STATED THAT HE'S ALLERGIC TO NICKEL AND WANTS TO KNOW IF THE IMPLANTS CONTAINED THE MINERAL. THE SYMPTOMS OF RASH OCCURRED ALMOST IMMEDIATELY AFTER SURGERY. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 4.0MM TI CERVICLE SELF-RETAIN SCREW. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Hypoesthesia; Itching Sensation

  MAUDE report 8188377 ↗
• InjuryAug 8, 2018Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGEON PERFORMED A C5-C6 ANTERIOR CERVICAL FUSION TO THE PATIENT USING AN 8MM FREEZE-DRIED LORDOTIC CORTICOCANCELLOUS ACF SPACER, A 16MM 1 LEVEL TITANIUM (TI) VECTRA-ONE PLATE AND TWO (2) L18 SELF-DRILLING CERVIC-SPINE-SCREW Ø4 DYNAM. AFTER FOLLOW-UP FOR POST-OPERATIVE PAIN IN CLINIC WITH IMAGING, IT WAS DISCOVERED THAT THE PATIENT HAD LOSS OF FIXATION AND NON-FUSION, AND A SURGICAL REVISION WAS SCHEDULED FOR (B)(6) 2018. DURING THE REVISION, IT WAS DISCOVERED THAT THE SCREW HAD PULLED OUT OF THE BONE AT C5 BUT DID NOT DISENGAGE FROM THE PLATE. THE MUSCULOSKELETAL TRANSPLANT FOUNDATION (MTF) SPACER HAD MIGRATED ANTERIORLY OUTSIDE OF THE DISC SPACE AND THE OTHER SCREW WAS STILL SECURELY PLACED IN THE BONE AT C6. ALL OF THE ORIGINAL IMPLANTS WERE REMOVED, AND PATIENT WAS REVISED TO A 9MM ACIS SPACER, 16MM VECTRA PLATE AND FOUR (4) 18MM SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES: TI VECTRA-ONE PLATE 1 LEVEL/16MM (PART: 04.613.156, LOT: UNKNOWN, QUANTITY: 1), 4.0MM TI CERVICAL SELF-RETAINING SCREW SELF-DRILLING/VA 18MM (PART: 04.613.518, LOT: UNKNOWN, QUANTITY: 1), CORT

  Patient problems: No Code Available; Pain

  MAUDE report 7762460 ↗