VIPER PRIME 186770440SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034530246), received between May 24, 2021 and Jun 17, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED DURING A PROCEDURE ON AN UNKNOWN DATE, THE SCREW WAS ATTACHED TO THE SCREWDRIVER BUT THEN FELL OFF AND BECAME UNCLEAN. THE SCREW DID NOT ATTACH TO THE SCREWDRIVER EASIER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25532545 ↗
• MalfunctionApr 2, 2025Migration; Migration

  IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION (L3) FOR OSTEOPOROTIC COMPRESSION FRACTURE ON (B)(6) 2025. IN THE SURGERY, THE SURGEON PERFORMED THE OPERATION USING NORMAL TECHNIQUES WITH VIPER PRIME FS SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. HOWEVER, LATER, WHEN INTRAOPERATIVE AND POSTOPERATIVE IMAGES WERE COMPARED, THERE WERE SIGNS THAT THE VIPER PRIME FS SCREW HAD SHIFTED SLIGHTLY FROM THE POSITION IT WAS PLACED IN DURING SURGERY. THEREFORE, THE SALES REP WAS POINTED OUT BY THE SURGEON THAT THE VIPER PRIME FS SCREW MAY HAVE MOVED DUE TO THE LOAD APPLIED WHEN BENDING THE TAB.

  Patient problems: Insufficient Information

  MAUDE report 21751711 ↗
• MalfunctionJul 11, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS A PLF (L4) AFTER OLIF FOR LUMBAR CANAL STENOSIS FROM TH10: SAI FUSION ON (B)(6) 2024. DURING THE SURGERY, THE SCREW IN QUESTION WAS INSERTED TO THE RIGHT OF L4 WITH PRIME NAVI DRIVER (PRODUCT CODE IS UNKNOWN), AND THE SCREWDRIVER AND SCREW ARE NO LONGER DETACHED. THE GREEN PART OF THE SCREWDRIVER WAS FOUND TO BE COMPLETELY LOOSE, BUT THEY DID NOT COME OFF. THE SURGEON PULLED A LITTLE HARDER AND THE SCREW CAME OUT WITH THE SCREWDRIVER. THEREFORE, A DIFFERENT SCREW (F7.0×45MM) WAS USED. NO BACKOUT WAS OBSERVED DURING ROD INSTALLATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 7X40MM S. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19724087 ↗
• 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 7 X 40MM THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: Joint Laxity; Nerve Damage; Osteolysis

  MAUDE report 18453163 ↗
• InjuryAug 2, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A FUSION (T9-L1) PERFORMED ON (B)(6) 2023. CEMENT WAS USED AT T9 AND L1. AFTER SURGERY, THE SCREWS AT L1 WERE FOUND TO BE LOOSE. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2023. THE CAUSE OF LOOSENING IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 7X40MM S THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17447162 ↗
• InjuryAug 2, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A FUSION (T9-L1) PERFORMED ON (B)(6) 2023. CEMENT WAS USED AT T9 AND L1. AFTER SURGERY, THE SCREWS AT L1 WERE FOUND TO BE LOOSE. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2023. THE CAUSE OF LOOSENING IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 7X40MM S. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17445585 ↗
• MalfunctionApr 25, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY (L1) FOR BURST FRACTURE OF LUMBAR VERTEBRA ON (B)(6) 2023. IN THE SURGERY, A BALLOON WAS INSERTED TO L1, THE PRIME FENESTRATED SCREWS WERE INSERTED TO TH12 AND L2. 1.0 CC OF THE CEMENT WAS INJECTED TO TH12. IMMEDIATELY AFTER SURGERY, THE CEMENT AT TH12 WAS FOUND TO BE INJECTED IN A SLIGHT UNUSUAL CONDITION, AND CT WAS TAKEN ON (B)(6) 2023. IT WAS CONFIRMED THAT THE PRIME FENESTRATED SCREW AT TH12 PROTRUDED OUTWARD FROM VERTEBRAL BODY, AND THE CEMENT LEAKED OUT OF VERTEBRAL BODY. THE SURGEON JUDGED THERE WAS NO PARTICULAR PROBLEM ON THIS EVENT BECAUSE THE PATIENT¿S CONDITION REMAINS UNCHANGED, AND THE PRIME FENESTRATED SCREW AT TH12 HAS A PROPER FIXITY. NO FURTHER INFORMATION IS AVAILABLE. REMARKS: (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (SYNTHES SPINE): CEMENT. (B)(4) (DEPUY SPINE): SCREW. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 7X40MM S THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806089 ↗
• MalfunctionMay 24, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR PRIMARY TRANSFORAMINAL INTERBODY FUSION L5/S1 SURGERY. DURING THE SURGERY, WHEN ATTEMPTING TO LOCK OFF SET SCREWS, THE ROD SLIPPED OUT OF THE TULIP AND SET SCREW WAS SPINNING IN HEAD OF SCREW DUE TO CROSS-THREADING. AFTER SEVERAL ATTEMPTS, THE SURGEON WAS ABLE TO LOOSEN THE SET SCREW, REMOVE IT AND RE-INTRODUCE X2 NEW SET SCREWS. THE PROCEDURE WAS THEN SAFELY COMPLETED. THE SURGERY WAS COMPLETED WITH TWENTY-FIVE (25) MINUTES SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR (1) VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 7 X 40MM. THIS REPORT IS 3 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870865 ↗