Modulus Expandable 1939132P2Recalls & reported problems
Nuvasive, Inc. · MOD-EX PL, 9x11x32mm 22° HL · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00195377056399), received between Aug 21, 2024 and Aug 21, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Collapse” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Collapse1
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.
MalfunctionAug 21, 2024Collapse; Collapse
ON (B)(6) 2024 A PATIENT UNDERWENT TRANSFORAMINAL INTERBODY LUMBAR FUSION PROCEDURE FROM L3-L4. THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2024 DURING A ROUTINE TWO MONTH FOLLOW UP APPOINTMENT IT WAS DISCOVERED VIA FILMS THAT THAT VERTEBRAL SPACER HAD COLLAPSED AND THE ALLOGRAPH HAD PARTIALLY EXTRUDED INTO THE SPINAL CANAL. . THE PATIENT WAS REPORTED TO HAVE BEEN SYMPTOMATIC. ON (B)(6), 2024 A REVISION TOOK PLACE TO REMOVE THE BONE GRAFT BUT THE SURGEONS PREROGATIVE WAS TO LEAVE THE HARDWARE IN PLACE WITH NO ADJUSTMENT.
Patient problems: Pain
MAUDE report 20012418 ↗
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- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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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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