PEEK PREVAIL™ Cervical Interbody Device 4210664Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994502094), received between Nov 21, 2016 and Mar 27, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionMar 27, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: CERVICAL SPONDYLOSIS, 5, 6, AND 7 DISCS PROTRUDING FROM THE NECK PROCEDURE: ANTERIOR CERVICAL DECOMPRESSION BONE GRAFT FUSION AND INTERNAL FIXATION LEVEL IMPLANTED: 2 (PROSTHESIS) IT WAS REPORTED THAT, INTRA-OP, THE NITINOL LOCKING RING ON THE PROSTHESIS WAS BROKEN. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. FRAGMENT REMAINED IN THE PATIENT. THE PATIENT HAS NOT UNDERGONE REVISION SURGERY. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8455033 ↗
• InjuryMar 13, 2017Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL SURGERY DUE TO INTER-VERTEBRAL DISC DEGENERATION ON (B)(6) 2016. ON AN UNKNOWN DATE, POST-OP, WIRE BREAKAGE WAS FOUND AND THE IMPLANTED SCREW BACKED OUT. THE LOCATION OF FRACTURE SCREW WAS IN WIRE, ABOUT THE NECK, C5-6. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 TO TAKE OUT THE SCREW. PEEK IMPLANT WAS NOT EXPLANTED BUT THE SCREW WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 6398600 ↗
• MalfunctionNov 21, 2016Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2016, INTRA-OP, PRODUCT BREAKAGE WAS FOUND AND SURGEON HAD TO REPLACE PRODUCT WITH A NEW ONE TO COMPLETE THE SURGERY SUCCESSFULLY. THE PATIENT GOT INTERBODY FUSION DUE TO CERVICAL DISC HERNIATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6116048 ↗