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T-PLIF 389.910Recalls & reported problems

Synthes GmbH · T-PLIF IMPLANT HOLDER · Class 1

All models of T-PLIF (11)

Data updated Oct 16, 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 10705034777245), received between Feb 24, 2023 and Feb 24, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Compatibility Problem” (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 16, 2026.

Most reported problems

Device problems

  • Compatibility Problem1
  • Material Integrity 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.

  • MalfunctionFeb 24, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, SURGEON FELT TIP WAS WARN CAUSING IMPLANT TO BE LOOSE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) T-PLIF IMPLANT HOLDER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16436802 ↗

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Sources and updates

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