ADD™ anterior distraction device CS 2250-12-166Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04052536009206), received between Jul 22, 2017 and Mar 29, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2018Use of Device Problem; Use of Device Problem

  PATIENT COMPLAINED SHE SUSTAINED PERMANENT PHYSICAL INJURIES AS A RESULT OF HER SURGERY. LIMITED INFORMATION WAS PROVIDED AND A COMPANY REPRESENTATIVE IS WORKING TO GET MORE INFORMATION ON THE CASE FROM THE HOSPITAL/SURGEON.

  Patient problems: Discomfort; Pain

  MAUDE report 7382078 ↗
• InjuryJul 22, 2017Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Malposition of Device

  DEVICE-RELATED MIGRATION FOLLOWING USE OF EXPANDABLE ADD VBR SMALL CAGE IN CONSTRUCT WITH 12MM X 15MM FOOTPRINT ENDPLATES AND 25MM HEIGHT WITH 6 DEGREE LORDOSIS. ASSEMBLED DEVICE WAS USED FOR SINGLE LEVEL ANTERIOR CERVICAL CORPECTOMY AND FUSION (ACCF) REPLACING C4 VERTEBRA. SURGEON IMPLANTED DEVICE UPSIDE DOWN AND NO DISCLOSURE USE OF THE DEVICE IN THE NECK HAD NOT BEEN FDA APPROVED OR CLEARED. CLINICALLY SIGNIFICANT SUBSIDENCE GREATER THAN 3MM EVIDENT ON IMAGING STUDIES RESULTING IN NEUROCOMPROMISE REQUIRING POSTERIOR REVISION SURGERY TO BE PERFORMED IN (B)(6) 2017. THE VBR CAGE WAS NOT APPROVED OR CLEARED FOR USE IN THE CERVICAL SPINE OF THE NECK AND SURGERY WAS RECORDED AS A TWO-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION PLUS CERVICAL CORPECTOMY AT C5, BUT IMAGING STUDIES SHOW CORPECTOMY WAS PERFORMED AT THE C4 LEVEL. NEW SURGEON STATES THE DEVICE SHOULD NOT HAVE BEEN USED IN THE FIRST PLACE.

  Patient problems: No Code Available; Spinal Cord Injury

  MAUDE report 6740030 ↗