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UNIPLATE 189707014Recalls & reported problems

Depuy Spine, LLC · UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM SCREW, SELF-DRILLING 4.6 x 14mm · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034180793), received between Aug 22, 2019 and Aug 22, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Migration3

Patient problems

  • No Code Available3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 22, 2019Migration; Migration

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL OF DEPUY SPINE UNIPLATE AND SCREWS, THE SCREW AT C7 HAS BEEN BACKED OUT FROM THE CERVICAL PLATE INTERFACE. THERE WERE NO KNOWN PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNIPLATE TWO LEVEL PLATE, 34MM (PART# 189722034S, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES.

    Patient problems: No Code Available

    MAUDE report 8920568 ↗
  • InjuryAug 22, 2019Migration; Migration

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL OF DEPUY SPINE UNIPLATE AND SCREWS, THE SCREW AT C7 HAS BEEN BACKED OUT FROM THE CERVICAL PLATE INTERFACE. THERE WERE NO KNOWN PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNIPLATE TWO LEVEL PLATE, 34MM (PART# 189722034S, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES THREE (3) DEVICES.

    Patient problems: No Code Available

    MAUDE report 8920501 ↗
  • InjuryAug 22, 2019Migration; Migration

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL OF DEPUY SPINE UNIPLATE AND SCREWS, THE SCREW AT C7 HAS BEEN BACKED OUT FROM THE CERVICAL PLATE INTERFACE. THERE WERE NO KNOWN PATIENT CONSEQUENCES. CONCOMITANT MEDICAL DEVICE: UNIPLATE TWO LEVEL PLATE, 34MM (PART# 189722034S, LOT# UNKNOWN, QUANTITY 1) . THIS COMPLAINT INVOLVES THREE (3) DEVICES.

    Patient problems: No Code Available

    MAUDE report 8920459 ↗

Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices

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