SOVEREIGN™ Spinal System 7967812Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994500915), received between Apr 28, 2017 and Apr 28, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 28, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS: L5-S1 DEGENERATIVE DISC DISEASE WITH SPONDYLOLISTHESIS. FOR WHICH, PATIENT UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION. INTRA-OP, THE PLATE WOULD NOT SNAP ON/CONNECT WITH THE CAGE IMPLANT. SURGEON ATTEMPTED THREE TIMES, AT WHICH POINT A SECONDARY IMPLANT OF THE SAME FOOT PRINT WAS OPENED AND THE NEW COVER PLATE WAS USED WITH THE ORIGINAL CAGE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATION WERE REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6529028 ↗