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ReLine 13450000Recalls & reported problems

Nuvasive, Inc. · RSS Lock Screw, 4.5/5.0mm · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517766021), received between Oct 15, 2019 and Feb 24, 2022 — classified as 2 injuries, 1 malfunction.

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

Most reported problems

Device problems

  • Expulsion2
  • Loose or Intermittent Connection1

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.

  • InjuryFeb 24, 2022Expulsion; Expulsion

    DURING A POST-OP FOLLOW-UP, A PHYSICIAN NOTICED THAT TWO (2) RELINE 4.5/5.0MM RSS LOCK SCREWS HAD COME LOOSE CAUSING THE INFERIOR END OF A ROD TO BECOME FREE-FLOATING IN THE PATIENT. A REVISION SURGERY WAS PERFORMED AND THE LOOSE LOCK SCREWS WERE REMOVED AND NEW LOCK SCREWS WERE PLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE SYMPTOMS. REPORT 2 OF 2.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13595936 ↗
  • InjuryFeb 24, 2022Expulsion; Expulsion

    DURING A POST-OP FOLLOW-UP, A PHYSICIAN NOTICED THAT TWO (2) RELINE 4.5/5.0MM RSS LOCK SCREWS HAD COME LOOSE CAUSING THE INFERIOR END OF A ROD TO BECOME FREE-FLOATING IN THE PATIENT. A REVISION SURGERY WAS PERFORMED AND THE LOOSE LOCK SCREWS WERE REMOVED AND NEW LOCK SCREWS WERE PLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE SYMPTOMS. REPORT 1 OF 2.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13595876 ↗
  • MalfunctionOct 15, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

    ON (B)(6) 2019, A PATIENT UNDERWENT A SPINAL PROCEDURE WITHOUT ANY REPORTED ISSUES. DURING A ROUTINE FOLLOW UP, RADIOGRAPH IMAGES IDENTIFIED A LOOSE SET SCREW. ON (B)(6) 2019, A REVISION PROCEDURE WAS PERFORMED WHERE THE SCREWS WERE REPLACED. NO PATIENT INJURY REPORTED.

    Patient problems: Failure of Implant

    MAUDE report 9194133 ↗

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.