ZEPHIR® Anterior Cervical System 8792813Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00721902610653), received between Feb 15, 2018 and Jun 12, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2019Migration; Migration

  PROCEDURE: ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). LEVELS IMPLANTED: C6-7. IT WAS REPORTED THAT POST-OP, CEPHALAD SCREW HAD BACKED OUT ANTERIORLY APPROXIMATELY 3MM, PAST THE LOCKING WIRE OF THE INTERBODY DEVICE WAS SHOWED IN X-RAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8690716 ↗
• InjuryFeb 15, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH BACKED OUT SCREW OF LEFT C3 AND UNDERWENT ANTERIOR CERVICAL DISCECECTOMY AND FUSION. POST-OP, SCREW HAD LOOSENED AT C3. THIS WAS OBSERVED IN THE FOLLOW UP ON (B)(6) 2017. THE PATIENT DID NOT STATE ANY DISCOMFORT, BUT DID MENTION A FALL FROM A STANDING POSITION TWO WEEKS PRIOR TO HIS FOLLOW UP VISIT. ON (B)(6) 2018, AN ATTEMPT WAS DONE TO REMOVE THE SCREW/HARDWARE BUT ABORTED DUE TO SCARRING

  Patient problems: Scarring

  MAUDE report 7272532 ↗
• InjuryFeb 15, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY WITH BACKING OUT OF LEFT C3 SCREW AND UNDERWENT ANTERIOR CERVICAL DISCECECTOMY AND FUSION. POST-OP, SCREW HAD LOOSENED AT C3. THIS WAS OBSERVED IN THE FOLLOW UP ON 20 DEC 2017. THE PATIENT DID NOT STATE ANY DISCOMFORT, BUT DID MENTION A FALL FROM A STANDING POSITION TWO WEEKS PRIOR TO HIS FOLLOW UP VISIT. ON (B)(6) 2018, AN ATTEMPT WAS DONE TO REMOVE THE SCREW/HARDWARE BUT ABORTED DUE TO SCARRING.

  Patient problems: Scarring

  MAUDE report 7272530 ↗