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ZIP ULTRARecalls & reported problems

Aurora Spine, Inc. · ZIP ULTRA MIS Interspinous Fusion System, 16mm x 45mm · Class 2

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 B521001016ZIP0), received between Apr 1, 2021 and Apr 1, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 1, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    ON (B)(6) 2021 A PHYSICIAN REPORTED THAT THE ZIP DEVICE DERAILED FROM ITSELF VENTRALLY DURING A LUMBAR FUSION. THE PHYSICIAN STATED METAL EDGES REMAINED IMPLANTED IN THE PATIENT POINTING TOWARDS THE DURA.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11606464 ↗

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