VIPER PRIME 186760445SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034530093), received between Sep 27, 2018 and Sep 13, 2024 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Device Slipped; Compatibility Problem; Device Slipped; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING 4-L5 STABILIZATION WITH CEMENT AUGMENTATION USING VIPER PRIME SCREWS AND CONFIDENCE CEMENT, THE SURGEON NOTICED THAT WHILE ATTEMPTING TO ATTACH THE SIZE 6.0X45MM VIPER PRIME SCREW TO THE VIPER PRIME MULTIFUNCTIONAL SCREW INSERTER, THE SCREW DID NOT FIT PROPERLY AND WAS LOOSE. AFTER THE CASE AN INSPECTION WAS CARRIED OUT BY FITTING THE SCREW INTO THE DRIVER, AND THE SCREW WASN'T STRAIGHT ON THE DRIVER. THE IMPACTED SCREW WAS TAKEN ASIDE AND ANOTHER SCREW WERE USED INSTEAD. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 6X45MM S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212772 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: 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, INSTABILITY, NEUROCOMPRESSION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 6 X 45MM. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: Joint Laxity; Nerve Damage; Osteolysis

  MAUDE report 18453387 ↗
• 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 6X45MM S. THIS IS REPORT 3 OF 4 FOR COMPLAINT: (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18450485 ↗
• MalfunctionOct 13, 2023Migration; Migration

  THE INITIAL COMPLAINT WAS REVIEWED, AND THE VIPER PRIME CFXFN XTB 6X45MM S WAS FOUND TO BE NOT REPORTABLE. AFTER RECEIPT OF ADDITIONAL INFORMATION, IT WAS CLARIFIED THAT THE SCREWS BECAME DAMAGED WHEN DOCKED ONTO THE BONE INTRAOPERATIVELY AND BECAME BLUNT, SO WOULD NOT ADVANCE. FRESH SCREWS WERE OPTIONED AND WORKED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930352 ↗
• MalfunctionOct 13, 2023Migration; Migration

  THE INITIAL COMPLAINT WAS REVIEWED, AND THE VIPER PRIME CFXFN XTB 6X45MM S WAS FOUND TO BE NOT REPORTABLE. AFTER RECEIPT OF ADDITIONAL INFORMATION, IT WAS CLARIFIED THAT THE SCREWS BECAME DAMAGED WHEN DOCKED ONTO THE BONE INTRAOPERATIVELY AND BECAME BLUNT, SO WOULD NOT ADVANCE. FRESH SCREWS WERE OPTIONED AND WORKED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930348 ↗
• InjurySep 25, 2023Migration; Migration

  THE IMPLANT HAS BEEN IN THE PATIENT FOR MORE THEN THREE MONTHS. THERE HAS NOT BEEN A REVISION SURGERY.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 17808911 ↗
• InjuryFeb 10, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FINLAND AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT A SURGEON FROM (B)(6) NEUROSURGERY WARD CONTACTED ME YESTERDAY EVENING ABOUT A VIPER PRIME L5/S1 FUSION WE DID ON (B)(6) 2022. THE RODS HAD SLIPPED OUT OF THE L5 SCREW AND THE VERTEBRAE HAS SLIPPED TO THE SAME POSITION AS IT WAS PREOPERATIVELY. I AM WAITING FOR POSSIBLE FURTHER INFORMATION BUT THIS IS ALL I KNOW AT THIS POINT. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 6X45MM S. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16358215 ↗
• MalfunctionAug 27, 2020Break; Break

  UPDATED EVENT DESCRIPTION: CONCOMITANT DEVICE REPORTED: VIPER PRIME CFXFN XTB 6X45MM S (PART# 186760445S, LOT# AVCBKY,, QUANTITY 1). 4.0 PLY SCREW 3.5X12 (PART# 102035112, LOT# 254654, QUANTITY 1). TI 4.0X030 LOR ROD (PART# 102064030, LOT# TBXUC, QUANTITY 1). SET SCREW (PART# 102000000, LOT# 238874, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459415 ↗
• 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 8667003 ↗
• InjurySep 27, 2018Break; Break

  PLEASE REFER TO THE LOCAL DESCRIPTION. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: REVISIONS OP, "8 PEDIKELSCHRAUBEN STATT 4." ACTION TAKEN FOR PROCEDURE: "ENTFERNUNG DER ABGEBROCHENEN VIPER PRIME SCHRAUBEN, EINBRINGEN VON 8 CFX SCHRAUBEN L4 BIS S2 UND ANSCHLIESSENDE ZEMENTAUGMENTATION." IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Not Applicable

  MAUDE report 7915614 ↗
• InjurySep 27, 2018Break; Break

  PLEASE REFER TO THE LOCAL DESCRIPTION. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: REVISIONS OP, "8 PEDIKELSCHRAUBEN STATT 4." ACTION TAKEN FOR PROCEDURE: "ENTFERNUNG DER ABGEBROCHENEN VIPER PRIME SCHRAUBEN, EINBRINGEN VON 8 CFX SCHRAUBEN L4 BIS S2 UND ANSCHLIESSENDE ZEMENTAUGMENTATION." IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Not Applicable

  MAUDE report 7915453 ↗