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VENTURE™ Anterior Cervical Plate System 9791325Recalls & reported problems

Medtronic Sofamor Danek, Inc. · BONE SCREW 9791325 4.0X15 SELF DRILL VAR · Class 2 · Implant

All models of VENTURE Anterior Cervical Plate System (9)

Data updated Oct 18, 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 00885074529745), received between Jan 21, 2019 and Jan 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (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 18, 2026.

Most reported problems

Device problems

  • Failure to Align1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 21, 2019Failure to Align; Failure to Align

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL SPONDYLOSIS AND UNDERWENT CERVICAL INTERNAL FIXATION SURGERY. DURING SURGERY, THE SCREW SLIPPED AND COULD NOT BE FIXED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8263462 ↗

Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices

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Sources and updates

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