VersaTie 8550002Recalls & reported problems
Nuvasive, Inc. · VersaTie Band, 5.5mm Dual Malleable End · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00887517721525), received between Nov 7, 2017 and Nov 7, 2017 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cancer1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION RECEIVED STATES LAMINAR BAND SAWED THROUGH BONE TISSUE. NO OTHER EVENT INFORMATION HAS BEEN PROVIDED OR RADIOGRAPHS THAT CONFIRM THE REPORTED EVENT. NO REVISION PROCEDURE WAS REPORTED.
Patient problems: Cancer
MAUDE report 7007365 ↗
Other Bone fixation cerclage, sublaminar devices
- TRANSLACE™ Spinal Tethering System 8219500Medtronic Sofamor Danek, Inc. · Bone fixation cerclage, sublaminar11 reports
- VersaTie 86101245Nuvasive, Inc. · Bone fixation cerclage, sublaminar4 reports
- KARMA 75035-175Spinal Elements, Inc. · Bone Fixation Cerclage, Sublaminar3 reports
- VersaTie 8510260Nuvasive, Inc. · Bone fixation cerclage, sublaminar3 reports
- LIGAPASS B08110005Medicrea International · Bone Fixation Cerclage, Sublaminar3 reports
- JAZZ LOCKImplanet · Bone Fixation Cerclage, Sublaminar3 reports
- NILE™ Alternative Fixation System 5416-F04730-SGVB Spine LLC · Bone fixation cerclage, sublaminar2 reports
- VersaTie 8450001Nuvasive, Inc. · Bone fixation cerclage, sublaminar2 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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