ACDF Stand Alone Cervical 03.18.622Recalls & reported problems
Medacta International SA · Mecta-C SA Drill Screw Lock Ø3.8x14 (2x) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040726603), received between Mar 31, 2021 and Dec 22, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
- Migration1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Migration or Expulsion of Device; Migration or Expulsion of Device
REVISION SURGERY 9 MONTHS AFTER THE PRIMARY DUE TO MECTA C SA PLATE FIXATION SCREW LOOSENING.
Patient problems: Insufficient Information
MAUDE report 23864344 ↗MalfunctionMay 6, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING SURGERY, INSIDE THE PACKAGING OF MECTA-C SA DRILL SCREWS LOCK Ø3.8X14 (X2) (REF 03.18.622 LOT 2465088), MECTA-C SA DRILL SCREWS LAG Ø3.8X14 (X2) (REF 03.18.632) WERE FOUND INSTEAD. NEW SCREWS LOCK OF DIFFERENT REF WERE USED TO COMPLETE SUCCESSFULLY THE SURGERY. SINCE THE SCREWS ARE NOT LOT-MARKED, IT WAS NOT POSSIBLE TO IDENTIFY THE LOT OF THE ITEMS FOUND INSIDE THE PACKAGING. BY REVIEWING THE PRODUCTION DATA SHIFT, IT WAS FOUND OUT THAT ON THE SAME DAY (06 DEC 2024), ONLY ONE SIMILAR PRODUCT (REF 03.18.632 LOT 2465090) HAS BEEN PACKAGED. THIS MATCHES THE PRODUCT THAT WAS FOUND UPON OPENING THE PACKAGING (REF 03.18.632) ALLOWING TO CONCLUDE THAT A FULL SWAP OF SUBCOMPONENTS OCCURRED BETWEEN THE TWO LOTS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21966279 ↗InjuryMar 31, 2021Migration; Migration
3 WEEKS AFTER THE PRIMARY SURGERY THE PATIENT HAD SEVERE CERVICAL SPINE PAIN, IT WAS RECOGNISED THAT ONE OF THE THREE PLATE SCREWS WAS TOTALLY UNSCREWED. THE PATIENT WAS REVISED IMMEDIATELY, REMOVING THE SCREW. DURING SURGERY IT WAS DISCOVERED THAT THE ESOPHAGUS WAS PERFORATED.
Patient problems: Failure of Implant; Pain
MAUDE report 11594893 ↗
Other Intervertebral Fusion Device With Integrated Fixation, Cervical devices
- NA 03.617.902Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical103 reports
- NA 03.617.900Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical77 reports
- Divergence® Anterior Cervical Fusion System G6626525Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical75 reports
- Divergence® Anterior Cervical Fusion System G6626526Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical49 reports
- NA 03.617.905Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical29 reports
- NA 03.617.904Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical27 reports
- Divergence® Anterior Cervical Fusion System G6626746Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical21 reports
- NA 03.647.972Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical17 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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