VIPER PRIME 186760450Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034509419), received between Jun 4, 2019 and Oct 11, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2024Crack; Compatibility Problem; Crack; Compatibility Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A & P LUMBAR FUSION ON (B)(6) 2024. DURING THE SURGERY, THE BAR IS NOT LOCKED WITH THE SLEEVE BECAUSE ONE OF THE PERCUTANEOUS SCREWS, HAD A BAD THREAD, AND IT HAS TO BE CHANGED TO OPEN SURGERY TO CHANGE IT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NINETY MINUTE DELAY. THIS REPORT IS FOR A VIPER PRIME CFXFEN XTAB 6X50MM.

  Patient problems: Insufficient Information

  MAUDE report 20427319 ↗
• InjuryJan 10, 2024Migration; Migration

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: IMPLANT MALPOSITION, KIDNEY / URINARY. COMPLICATION TIME/INTERVENTION POSTOPERATIVE (BEFORE DISCHARGE) THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFEN XTAB 6X50MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18483718 ↗
• InjuryJan 5, 2024Migration; Migration

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: IMPLANT MALPOSITION, KIDNEY / URINARY, COMPLICATION TIME/INTERVENTION. POSTOPERATIVE (BEFORE DISCHARGE). THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFEN XTAB 6X50MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18460091 ↗
• InjurySep 29, 2020Break; Break

  THE PREVIOUS HARDWARE WAS PARTIALLY REMOVED AND NEW HARDWARE WAS INSERTED TO TWO ADDITION LEVELS BILATERALLY. PORTION OF LEFT SIDED SCREWS WERE IMPACTED IN BONE AND COULD NOT BE RETRIEVED. THE BROKEN SCREWS WERE ENCASED IN BONE TOO ANTERIOR IN THE VERTEBRAL BODY; RETRIEVAL WOULD HAVE BEEN DAMAGING TO THE INTEGRITY OF THE ANATOMY. IT WAS ALSO REPORTED THE L4/L5 REGION WAS NOT FUSED AND STILL MOBILE AND THE PATIENT EXPERIENCED A LITTLE PAIN. IT WAS NOTED THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT ((B)(4)) CAPTURES THE POST-OPERATIVELY BROKEN SCREWS. RELATED COMPLAINT ((B)(4)) CAPTURES THE INTRA-OPERATIVE EVENT OF THE SCREWS IMPACTED IN BONE NOT BEING ABLE TO BE REMOVED.

  Patient problems: Failure of Implant; No Code Available; Pain

  MAUDE report 10600385 ↗
• MalfunctionJun 4, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2019, THE THREE (3) VIPER PRIME SCREWS HAD TO BE REPLACED INTRAOPERATIVELY DUE TO LACK OF PULL OUT STRENGTH OR INAPPROPRIATE SCREW LENGTH. AFTER REPLACEMENT OF THE SCREWS, THE OR NURSE WANTED THEM TO BE STERILIZED FOR DEMONSTRATION PURPOSE. AFTER STERILIZATION, TWO (2) OF THE THREE (3) SCREWS FELL APART IN 3 PIECES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. . THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8666958 ↗
• MalfunctionJun 4, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2019, THE THREE (3) VIPER PRIME SCREWS HAD TO BE REPLACED INTRAOPERATIVELY DUE TO LACK OF PULL OUT STRENGTH OR INAPPROPRIATE SCREW LENGTH. AFTER REPLACEMENT OF THE SCREWS, THE OR NURSE WANTED THEM TO BE STERILIZED FOR DEMONSTRATION PURPOSE. AFTER STERILIZATION, TWO (2) OF THE THREE (3) SCREWS FELL APART IN 3 PIECES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8666826 ↗