Monolith 5992537Recalls & reported problems
Nuvasive, Inc. · Monolith Endcap, 15x13mm Lord 7° Ø12 · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517677365), received between Jul 18, 2017 and Jul 18, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Device Operates Differently Than Expected1
Patient problems
- Ambulation or Postural Difficulties1
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2017Device Operates Differently Than Expected
DEVICE-RELATED FAILURE OF MODULAR (STACKABLE) MONOLITH (B)(4) PROCODE MQP RESULTING IN SERIOUS NEUROCOMPROMISE RENDERING PATIENT PARALYZED FOLLOWING SINGLE-LEVEL C6 ANTERIOR CERVICAL CORPECTOMY AND FUSION (ACCF). PATIENT REQUIRED POSTERIOR REVISION SURGERY POST-OP SIX MONTHS AND IS RELEARNING TO WALK AGAIN. THE MONOLITH DEVICE WAS EXPLICITLY CLEARED FOR USE BELOW THE NECK IN THE THORACOLUMBAR SPINE, BUT IS IN LORDOTIC CAGE GEOMETRY AND DESIGN RATIONALE INTENDED FOR USE IN THE CERVICAL SPINE AND CANNOT POSSIBLY BE USED FOR ITS LABELED PURPOSE. DEVICE COMPONENT PART NUMBERS INCLUDE: 5991220, 5991153, 5992537.
Patient problems: Ambulation or Postural Difficulties; Failure of Implant
MAUDE report 6728303 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.