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Vu a-POD Prime NanoMetalene 35-14-1210Recalls & reported problems

Seaspine Orthopedics Corporation · Prime NM Implant, 31x24mm x 12mm, 10 Deg · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889981126490), received between Mar 18, 2021 and Mar 18, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Patient Device Interaction Problem2

Patient problems

  • Unspecified Infection2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 18, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

    A TOTAL OF FOUR INFECTION EVENTS HAVE BEEN REPORTED IN FOUR PATIENTS UTILIZING ALIF SURGICAL APPROACH AND SEASPINE VU A·POD¿ PRIME NM PRODUCT FAMILY. THREE OF FOUR PATIENTS RECEIVED A SINGLE-LEVEL SURGERY; THE FOURTH PATIENT UNDERWENT A TWO-LEVEL PROCEDURE. NON-SPECIFIC PATIENT IDENTIFIERS AND INDEX SURGERY DATES HAVE BEEN PROVIDED. ALL PATIENTS WERE REPORTED TO HAVE SUBSEQUENTLY UNDERGONE REOPERATION CONSISTING OF SURGICAL SITE DEBRIDEMENT FOLLOWED BY ANTIBIOTIC TREATMENT. CULTURE RESULTS AND SENSITIVITY ARE NOT KNOWN. OTHER POTENTIALLY PERTINENT PATIENT CHARACTERISTICS SUCH AS COMORBIDITIES, PRIOR SURGICAL HISTORY AND EXTENT OF INDEX SURGERY ARE NOT KNOWN (E.G., ADDITIONAL STABILIZATION). RELATED SUBMISSIONS: 3012120772-2021-00023, 3012120772-2021-00024, AND 3012120772-2021-00026.

    Patient problems: Unspecified Infection

    MAUDE report 11516130 ↗
  • InjuryMar 18, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

    A TOTAL OF FOUR INFECTION EVENTS HAVE BEEN REPORTED IN FOUR PATIENTS UTILIZING ALIF SURGICAL APPROACH AND SEASPINE VU A·POD¿ PRIME NM PRODUCT FAMILY. THREE OF FOUR PATIENTS RECEIVED A SINGLE-LEVEL SURGERY; THE FOURTH PATIENT UNDERWENT A TWO-LEVEL PROCEDURE(3012120772-2021-00024). NON-SPECIFIC PATIENT IDENTIFIERS AND INDEX SURGERY DATES HAVE BEEN PROVIDED. ALL PATIENTS WERE REPORTED TO HAVE SUBSEQUENTLY UNDERGONE REOPERATION CONSISTING OF SURGICAL SITE DEBRIDEMENT FOLLOWED BY ANTIBIOTIC TREATMENT. CULTURE RESULTS AND SENSITIVITY ARE NOT KNOWN. OTHER POTENTIALLY PERTINENT PATIENT CHARACTERISTICS SUCH AS COMORBIDITIES, PRIOR SURGICAL HISTORY AND EXTENT OF INDEX SURGERY ARE NOT KNOWN (E.G., ADDITIONAL STABILIZATION). RELATED SUBMISSIONS: 3012120772-2021-00023, 3012120772-2021-00024, 3012120772-2021-00025, 3012120772-2021-00026.

    Patient problems: Unspecified Infection

    MAUDE report 11516119 ↗

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Sources and updates

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