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ReLine 16186535Recalls & reported problems

Nuvasive, Inc. · RELINE MAS MOD Screw Shank, 6.5x35mm 2C · 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 00887517654847), received between Jul 7, 2020 and Jul 7, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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

  • Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

  • Pain1

Recent adverse event reports

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

  • MalfunctionJul 7, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    A PATIENT REPORTED VIA VOICEMAIL TO HAVE UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE, LAMINECTOMY AT L4-5 AND L5-S1 LEVELS WITH POSTERIOR FIXATION FROM L4 -S1 WITH ELECTROPYSIOLOGIC MONITORING, ALONG WITH COMPLETE RIGHT SIDED FACETECTOMIES AND LEFT POSTEROLATERAL ARTHRODESIS AND FUSION ON (B)(6) 2019. LESS THAN A YEAR LATER THE PATIENT BEGAN TO EXPERIENCE PAIN WHICH HAS CONTINUED TO DATE. A POST-OPERATIVE CT SCAN IDENTIFIED TWO LOOSE SCREWS AT UNCONFIRMED POSITIONS.

    Patient problems: Pain

    MAUDE report 10243183 ↗

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