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Modulus 67940002P2Recalls & reported problems

Nuvasive, Inc. · Modulus Cervical, 7x15x12mm 7° · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517959003), received between Aug 1, 2023 and May 9, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Migration” (2 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Migration2
  • Migration or Expulsion of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Failure of Implant1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 9, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

    THE PATIENT HAS PRIMARY SURGERY TO INSERT MODULUS CERVICAL CAGE INTO C6/C7 ON (B)(6) 2025 BECAUSE OF KYPHOSIS, CERVICAL HERNIA. AFTER THE SURGERY, THE CAGE BACKED OUT ABOUT HALFWAY FROM THE INTERVERTEBRAL SPACE. ON (B)(6) 2025 THE SURGEON REINSERTED THE CAGE AND FIXED THE VERTEBRAL BODY WITH A PLATE FROM ANOTHER MANUFACTURER. THE SURGEON SAID THAT THE PATIENT HAD A KYPHOSIS, AND THE WEIGHT ON THE FRONT OF THE VERTEBRAL BODY WAS TOO STRONG, WHICH MAY HAVE CAUSED THE CAGE TO BACK OUT. HE THINKS IT MAY HAVE BEEN BETTER TO HAVE PLACED IT A LITTLE FURTHER BACK FROM THE BEGINNING. AND THERE WAS NO EXTERNAL FIXATION AFTER THE SURGERY, SO THAT MAY HAVE BEEN THE CAUSE, AND HE THOUGHT THAT THERE WAS NO PROBLEM WITH THE CAGE. WE DO NOT RECEIVE ANY OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.

    Patient problems: Failure of Implant

    MAUDE report 21994027 ↗
  • MalfunctionAug 2, 2023Migration; Migration

    THIS COMPLAINT WAS DISCOVERED DURING THE INVESTIGATION OF COMPLAINT (B)(4). ON A (B)(6) 2021 A PATIENT UNDERWENT AN ANTERIOR CERVICAL PROCEDURE FROM C5 TO C7. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. ON A (B)(6) 2022 DATE IT WAS DISCOVERED DURING A POST-OP FOLLOW UP X-RAY NOTED INFERIOR/SUPERIOR SUBSIDENCE OF THE INTERBODY¿S AT C5-6 AND C6-7 AS WELL AS THE IDENTIFIED PSEUDOARTHROSIS (RADIOLUCENCY) AT THE SCREW TO BONE INTERFACE AT C5, C6 AND C7. THE PATIENT WAS EXPERIENCING NO ADVERSE EFFECTS AS A CONSEQUENCE OF THE ISSUE AND NO REVISION IS PLANNED. 2 OF 2.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17440182 ↗
  • MalfunctionAug 1, 2023Migration; Migration

    THIS COMPLAINT WAS DISCOVERED DURING THE INVESTIGATION OF COMPLAINT (B)(4). ON A (B)(6)2021 A PATIENT UNDERWENT AN ANTERIOR CERVICAL PROCEDURE FROM C5 TO C7. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. ON A (B)(6)2022 DATE IT WAS DISCOVERED DURING A POST-OP FOLLOW UP X-RAY NOTED INFERIOR/SUPERIOR SUBSIDENCE OF THE INTERBODY¿S AT C5-6 AND C6-7 AS WELL AS THE IDENTIFIED PSEUDOARTHROSIS (RADIOLUCENCY) AT THE SCREW TO BONE INTERFACE AT C5, C6 AND C7. THE PATIENT WAS EXPERIENCING NO ADVERSE EFFECTS AS A CONSEQUENCE OF THE ISSUE AND NO REVISION IS PLANNED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17438922 ↗

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