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NA 698344246Recalls & reported problems

Depuy Spine, LLC · MODIFIED INSTRUMENT GUIDE, SHORT · Class 1

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 10705034564708), received between Sep 29, 2022 and Sep 29, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

  • Device-Device Incompatibility1
  • Material Deformation1

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.

  • MalfunctionSep 29, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

    IT WAS REPORTED THAT ON (B)(6) 2022, THE BENT TINE OF THE INSTRUMENT IN QUESTION WAS NOT ENGAGING THE IMPLANT. THERE WAS NO IMPACT TO THE PATIENT OR THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MODIFIED INSTRUMENT GUIDE, SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15508612 ↗

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