ADDplus™ anterior distraction device plus CS 2253-12-40Recalls & reported problems
Ulrich GmbH & Co. KG · ADDplus, ø 12 mm, height 40-65 mm, angle 18° · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04052536009381), received between Jul 27, 2017 and Jul 27, 2017 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Paresis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2017Adverse Event Without Identified Device or Use Problem
LITERATURE NIGRO L., TARANTINO, R., DONNARUMMA, P., SANTORO, A., & DELFINI, R. (2017). C5 PALSY AFTER INSERTION OF A WINGED EXPANDABLE CERVICAL CAGE: A CASE REPORT AND LITERATURE REVIEW. JOURNAL OF SPINE SURGERY. STUDY REPORTED CASE STUDY IN WHICH PT WAS IMPLANTED WITH ADDPLUS DEVICE FOR THREE-LEVEL ANTERIOR CERVICAL CORPECTOMY AND FUSION RESULTING IN C5 PALSY. "WE SUPPOSE THAT THE PREEXISTING FORAMINAL STENOSIS, WIDE ANTERIOR DECOMPRESSION AND PARTIAL IMPROVEMENT OF CERVICAL ALIGNMENT WERE ALL FACTORS CONTRIBUTING TO THE PALSY."
Patient problems: Paresis
MAUDE report 6753661 ↗
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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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