UNIPLATE 189706114Recalls & reported problems
Depuy Spine, LLC · UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM LARGE DIAMETER SCREW 5.2 x 14mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034180694), received between Mar 23, 2021 and Mar 23, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Slipped” (2 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
- Device Slipped2
Patient problems
- Failure of Implant2
- Unspecified Tissue Injury2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2021Device Slipped; Device Slipped
IT WAS REPORTED THAT THE PATIENTS HARDWARE BECOME LOOSE DUE TO POOR BONE QUALITY AND NON COMPLIANCE. PATIENT IS STATUS POST 3 LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). INITIAL PROCEDURE WAS PERFORMED ON (B)(6) 2021. PATIENT HARDWARE WAS EXPLANTED ON (B)(6) 2021. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) UNIPLATE LRG DIA, 14MM. THIS IS REPORT 6 OF 6 FOR (B)(4).
Patient problems: Failure of Implant; Unspecified Tissue Injury
MAUDE report 11558298 ↗InjuryMar 23, 2021Device Slipped; Device Slipped
IT WAS REPORTED THAT THE PATIENTS HARDWARE BECOME LOOSE DUE TO POOR BONE QUALITY AND NON COMPLIANCE. PATIENT IS STATUS POST 3 LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). INITIAL PROCEDURE WAS PERFORMED ON (B)(6) 2021. PATIENT HARDWARE WAS EXPLANTED ON (B)(6) 2021. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) UNIPLATE LRG DIA, 14MM. THIS IS REPORT 3 OF 6 FOR (B)(4).
Patient problems: Failure of Implant; Unspecified Tissue Injury
MAUDE report 11558293 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Elegance® Anterior Cervical Plate 53430353Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430108Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430114Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430240Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430236Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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