MAS PLIF 7070000Recalls & reported problems

Nuvasive, Inc. · MAS PLIF Tulip, Modular · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887517204028), received between May 22, 2017 and May 7, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Detachment Of Device Component2
Break1
Loose or Intermittent Connection1

Patient problems

Failure of Implant4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 7, 2018Break; Break
A PATIENT UNDERWENT INDEX SURGERY ON (B)(6) 2017 FOR A SINGLE LEVEL CORTICAL SCREW FUSION FROM L3 TO L4 LEVEL. ON (B)(6) 2018 A REVISION PROCEDURE WAS PERFORMED TO EXTEND THE FUSION OF L3-S1 LEVELS. DURING A ROUTINE FOLLOW UP IT AS DISCOVERED THAT A SCREW ON THE RIGHT SIDE OF THE L4 LEVEL HAD FRACTURED. AS PER REPORTER, PATIENT IS ASYMPTOMATIC AND NO REVISION PROCEDURE WILL BE PERFORMED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 7492670 ↗
MalfunctionApr 17, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
ON (B)(6) 2017 PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE ON L4-S1 LEVELS. ON (B)(6) 2018 A REVISION PROCEDURE WAS PERFORMED TO DUE TO LOOSEN BILATERAL SCREWS AT THE S1 LEVEL. THE PATIENT IS REPORTED TO BE DOING WELL POST REVISION PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 7436570 ↗
MalfunctionJan 5, 2018Detachment Of Device Component; Detachment Of Device Component
ON (B)(6) 2017 A PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE. ON (B)(6) 2017 FOLLOW UP RADIOGRAPHS SHOWED A TULIP SEPARATION AT L3 LEVEL. ON (B)(6) 2017 A REVISION PROCEDURE TOOK PLACE WHERE THE SCREW WAS REMOVED AND REPLACED WITH NO REPORTED ISSUES. NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 7168520 ↗
MalfunctionMay 22, 2017Detachment Of Device Component; Detachment Of Device Component
ON (B)(6) 2016 A (B)(6) Y/O FEMALE PATIENT UNDERWENT POSTERIOR FIXATION SURGERY FROM L5-S1 WITH NO REPORTED ISSUES. DURING A FOLLOW UP APPOINTMENT A TULIP SEPARATION WAS OBSERVED AT L5. ON (B)(6) 2017 A REVISION SURGERY WAS PERFORMED. NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 6583657 ↗

Device details

UDI-DI	`00887517204028`
Brand	MAS PLIF
Model	7070000
Company	Nuvasive, Inc.
Product code	NKB · Orthosis, spinal pedicle fixation, for degenerative disc disease
Class	Class 2
FDA submission	K102514
Implant	Yes
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 11, 2025

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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All Orthosis, spinal pedicle fixation, for degenerative disc disease devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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