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ReLine 16016540Recalls & reported problems

Nuvasive, Inc. · RELINE MAS Screw, 6.5x40mm 2C Polyaxial · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517553577), received between Jul 29, 2022 and Jul 29, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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 Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 29, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

    ON (B)(6) 2021 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM T10 TO S2AI WHERE THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2022 IT WAS REPORTED THAT THE PEDICLE SCREW AT T10 HAS BACKED OUT AND THE SCREW TIP WAS FOUND TO BE IN CRANIAL DIRECTION. ON (B)(6) 2022 A REVISION PROCEDURE OCCURRED WHERE THE SCREWS AT BOTH SIDES T10 WERE REMOVED AND PEDICLE SCREWS WERE ADDED AT T6-T9, AND THE RODS AT T6-T9 WERE CONNECTED TO THE CAUDAL RODS WITH INLINE CONNECTORS. THE PATIENT IS DOING WELL POST REVISION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15130994 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

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