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VIPER 286760350Recalls & reported problems

Depuy Spine, LLC · VIPER 2 SYSTEM EXT. TAB INSERTION SLEEVE · Class 1

All models of VIPER (60)

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

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 10705034214955), received between Feb 26, 2022 and Feb 26, 2022 — classified as 1 malfunction.

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

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionFeb 26, 2022Break; Break

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A TLIF (S1) FOR TREATING LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2022, THE RING ON THE SLEEVE CAME OFF DURING SLEEVE TURNING FOR SCREW DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH NO DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A VIPER INSERTION SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13608656 ↗

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Sources and updates

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