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VersaTie 8510260Recalls & reported problems

Nuvasive, Inc. · VersaTie Clamp, 5-6mm Side Loading · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517709875), received between Apr 25, 2019 and Aug 27, 2020 — classified as 1 injury, 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
  • Output above Specifications1

Patient problems

  • Bone Fracture(s)1
  • Failure of Implant1
  • Pain1
  • Spinal Column Injury1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 27, 2020Material Rupture; Material Rupture

    ON (B)(6) 2020, PATIENT UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASONS WHERE THE CONSTRUCT WAS EXTENDED TO THE L2 LEVEL AND SUBLAMINAR BONE FIXATION CERCLAGE WAS UTILIZED. AN ADDITIONAL REVISION PROCEDURE WAS REPORTED TO HAVE OCCURRED ON (B)(6) 2020 FOR UNKNOWN REASONS AND IT WAS IDENTIFIED THAT IMPLANTED BANDS HAD RUPTURED. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Failure of Implant

    MAUDE report 10462716 ↗
  • MalfunctionAug 7, 2020Material Rupture; Material Rupture

    PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2019, WHERE THE CONSTRUCT WAS EXTENDED TO THE T10 LEVEL. THE PATIENT BEGAN TO EXPERIENCE PAIN AT THE TOP OF THE CONSTRUCT. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER REPORTER, IT WAS CONFIRMED THAT 4 OF THE 6 IMPLANTED BANDS HAD RUPTURED, WHICH IN TURN HAD LOOSENED THE CONSTRUCTS SCREWS. THE PATIENT REPORTED NO ISSUES POST THE REVISION PROCEDURE.

    Patient problems: Pain

    MAUDE report 10377330 ↗
  • InjuryApr 25, 2019Output above Specifications; Output above Specifications

    ON (B)(6) 2019 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE UTILIZING THE VERSATIE SYSTEM. AS PER REPORTER WHILE TENSION WAS BEING PERFORMED THE BAND RIPPED THE SPINOUS PROCESS. THE SURGEON MOVED TO THE NEXT LEVEL AND THE SAME THING OCCURRED. ALTERNATIVE FIXATION DEVICE WAS UTILIZED. THE PATIENT WAS REPORTED TO HAVE RE-COOPERATED.

    Patient problems: Bone Fracture(s); Spinal Column Injury

    MAUDE report 8547866 ↗

Other Bone fixation cerclage, sublaminar devices

All Bone fixation cerclage, sublaminar devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.