VIPER PRIME 186760440SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034530086), received between Feb 22, 2021 and Jan 5, 2024 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: ADJACENT SEGMENT PATHOLOGY COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 6X40MM S THIS IS REPORT 2 OF 4 FOR COMPLAINT PC--(B)(4).

  Patient problems: Osteolysis

  MAUDE report 18451023 ↗
• InjuryOct 10, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  UPON EXAMINATION AFTER SURGERY, THE SURGEON COMMENTED THAT THIS EVENT HAD NO CAUSAL RELATIONSHIP TO THE CEMENT AND WAS NOT CAUSED BY THE SURGICAL TECHNIQUE. THE SURGEON ALSO COMMENTED THAT THIS EVENT APPEARS TO HAVE BEEN CAUSED BY BLOOD CLOT EMBOLISM IN THE LOWER LIMBS, AND THE PATIENT IS CURRENTLY IN STABLE CONDITION, HAVING BEEN PLACED ON AN ECMO AND TRYING TO REST.

  Patient problems: Pulmonary Embolism

  MAUDE report 17905380 ↗
• InjuryOct 10, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  UPON EXAMINATION AFTER SURGERY, THE SURGEON COMMENTED THAT THIS EVENT HAD NO CAUSAL RELATIONSHIP TO THE CEMENT AND WAS NOT CAUSED BY THE SURGICAL TECHNIQUE. THE SURGEON ALSO COMMENTED THAT THIS EVENT APPEARS TO HAVE BEEN CAUSED BY BLOOD CLOT EMBOLISM IN THE LOWER LIMBS, AND THE PATIENT IS CURRENTLY IN STABLE CONDITION, HAVING BEEN PLACED ON AN ECMO AND TRYING TO REST.

  Patient problems: Pulmonary Embolism

  MAUDE report 17905341 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE SCREWS IN QUESTION ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. AFTER THE SURGERY, ON AN UNKNOWN DATE, A FRACTURE OF THE VERTEBRAL BODY OCCURRED. ALTHOUGH THE PATIENT FEELS PAIN, THERE ARE NO PLANS FOR A REVISION SURGERY. THE PATIENT STATUS WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 X 40MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 16502681 ↗
• InjuryMar 25, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A REVISION SURGERY OF A TLIF MIS WITH VIPER PRIME SCREWS WAS DONE ON (B)(6) 2022 BECAUSE TWO SCREWS BROKE POSTOPERATIVELY AND THERE WAS A NONUNION. THE FIRST SURGERY WAS DONE ON (B)(6) 2019. DURING THE REVISION SURGERY, THE TIP OF THE EXPEDIUM SCREWDRIVER BROKE. NO FURTHER INFORMATION PROVIDED. THIS REPORT CAPTURES THE POSTOP EVENT OF SCREWS BREAKAGE WHILE RELATED COMPLAINT (B)(4) CAPTURES THE INTRA-OP EVENT OF SCREWDRIVER BREAKAGE. THIS REPORT IS FOR (1) VIPER PRIME CFXFN XTB 6X40MM S. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13904909 ↗
• InjuryMar 25, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A REVISION SURGERY OF A TLIF MIS WITH VIPER PRIME SCREWS WAS DONE ON (B)(6) 2022 BECAUSE TWO SCREWS BROKE POSTOPERATIVELY AND THERE WAS A NONUNION. THE FIRST SURGERY WAS DONE ON (B)(6) 2019. DURING THE REVISION SURGERY, THE TIP OF THE EXPEDIUM SCREWDRIVER BROKE. NO FURTHER INFORMATION PROVIDED. THIS REPORT CAPTURES THE POSTOP EVENT OF SCREWS BREAKAGE WHILE RELATED COMPLAINT (B)(4) CAPTURES THE INTRA-OP EVENT OF SCREWDRIVER BREAKAGE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 6X40MM S. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4)

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13904884 ↗
• InjuryJul 30, 2021Break; Break

  CONCOMITANT DEVICES: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QTY 2). UNKNOWN LOCKING/SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12253631 ↗
• InjuryJul 30, 2021Break; Break

  CONCOMITANT DEVICES: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QTY 2). UNKNOWN LOCKING/SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12253424 ↗
• MalfunctionFeb 22, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY OF LUMBAR DISC NUCLEUS PULPOSUS RESECTION WITH CONICAL LAMINECTOMY, THE STERILE PACKING WAS OPENED, BUT THE PRODUCT WAS NOT THE ONE EXPECTED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT A LABELLING ISSUE HAD OCCURRED. THIS REPORT IS FOR A VIPER PRIME CFXFN XTB 6X40MM S. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359440 ↗