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Modulus 67940049P2Recalls & reported problems

Nuvasive, Inc. · Modulus Cervical, 8x17x14mm 10° · Class 2 · Implant

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517959607), received between Oct 21, 2019 and Jul 17, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Migration or Expulsion of Device3
  • Migration1

Patient problems

  • Failure of Implant4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 17, 2020Migration; Migration

    NEW OR UPDATED INFORMATION FOUND ON SECTIONS: D7,H6, H10.

    Patient problems: Failure of Implant

    MAUDE report 10287443 ↗
  • MalfunctionJul 1, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

    A PATIENT UNDERWENT A CERVICAL SPINE PROCEDURE ON (B)(6) 2020, WHERE A CERVICAL SPACER CAGE WAS USED STAND ALONE DEVICE WITH NO ADDITIONAL FIXATION OR PLATING. AROUND A WEEK POST-OP THE PATIENT BEGAN TO HAVE DIFFICULTY SWALLOWING AND IT WAS DISCOVERED THAT THE IMPLANTED CAGE HAD MIGRATED ANTERIORLY. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020 WHERE THE MODULUS-C WAS REPLACED WITH ANOTHER MANUFACTURERS DEVICE. THE PATIENT WAS REPORTED AS DOING WELL POST REVISION PROCEDURE.

    Patient problems: Failure of Implant

    MAUDE report 10221502 ↗
  • MalfunctionJun 29, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

    UPDATED INFORMATION LOCATED ON SECTIONS: D4, H2, H6, H10.

    Patient problems: Failure of Implant

    MAUDE report 10208867 ↗
  • MalfunctionOct 21, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

    ON (B)(6) 2019 PATIENT UNDERWENT A CERVICAL PROCEDURE AT LEVELS C5-C6 IN WHICH A SPACER WAS IMPLANTED. DURING A ROUTINE FOLLOW UP, RADIOGRAPHS IDENTIFIED THAT THE IMPLANT HAD MIGRATED ANTERIORLY. AS PER REPORTER, THE PATIENT HAD DIFFICULTY SWALLOWING. PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY A WEEK AFTER WITHOUT ANY REPORTED ISSUES. AS PER REPORTER, THE PATIENT IS DOING WELL POST-REVISION PROCEDURE.

    Patient problems: Failure of Implant

    MAUDE report 9216493 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.