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EIT PLIF Trial PET20810Recalls & reported problems

EIT Emerging Implant Technologies GmbH · Trial, H: 8 mm, 4°, 30/9 · 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 04260397083642), received between Aug 10, 2022 and Aug 10, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K170503); they may or may not involve this specific model.

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

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.

  • MalfunctionAug 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 TRIAL H8MM WAS NOT HOLDING / CLIPPING ON THE HANDLE PROPERLY ANYMORE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) TRIAL H 8MM 4DEG 30/9. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15204743 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170503. One submission often covers many models, so check the product and lot details in each record.

  • Z-1324-2022 · May 20, 2022 · Open, Classified
    EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD
  • Z-1323-2022 · May 20, 2022 · Open, Classified
    EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD

Other Intervertebral Fusion Device With Bone Graft, Lumbar devices

All Intervertebral Fusion Device With Bone Graft, Lumbar devices →

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