VersaTie 8450001Recalls & reported problems
Nuvasive, Inc. · VersaTie Band, 4.5mm Hook-Malleable End · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517794857), received between Jun 5, 2020 and Aug 12, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Rupture2
Patient problems
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2020Material Rupture; Material Rupture
IT WAS REPORTED PATIENT WAS EXPERIENCING PAIN POST-OPERATIVE AT THE TOP OF THE CONSTRUCT AND RADIOGRAPHS REVEALED THAT IMPLANTED BANDS RUPTURED. DURING THE REVISION PROCEDURE THE SURGEON NOTED THAT 3 OF THE 4 IMPLANTED BANDS HAD RUPTURED, WHICH IN TURN HAD LOOSENED THE CONSTRUCTS.
Patient problems: Pain
MAUDE report 10394512 ↗MalfunctionJun 5, 2020Material Rupture; Material Rupture
IT WAS REPORTED PATIENT WAS EXPERIENCING LEFT SIDE PAIN AS PER REPORTER, XRAY FILMS IDENTIFIED LEFT BAND RUPTURED AND RIGHT BAND TO BE LOOSENED. PATIENT HAS UNDERGONE A REVISION PROCEDURE WHERE PRODUCT WAS REPLACED WITH OTHER MANUFACTURERS PRODUCT.
Patient problems: Pain
MAUDE report 10123063 ↗
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
- TRANSLACE™ Spinal Tethering System 8205300Medtronic Sofamor Danek, 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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