VIPER PRIME 186770340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034530178), received between Jun 17, 2020 and Mar 12, 2026 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Device-Device Incompatibility; Migration

  IT WAS REPORTED THAT POST IBF UI H 9MM 4DEG 22/9 AND VIPER PRIME CFX XTAB 7X40MM TI WERE INVOLVED IN A REPORTED EVENT. FOLLOWING A POSTERIOR LUMBAR INTERBODY FUSION FOR LUMBAR SPINAL CANAL STENOSIS, THE CAGE BACKED OUT ONE WEEK AFTER SURGERY, NECESSITATING A REOPERATION. THE CAGE WAS REINSERTED AND ONE SCREW WAS REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS, AND THE EVENT RESULTED IN A CORRECTIVE INVASIVE PROCEDURE WHERE A DEVICE WAS REPLACED OR REVISED.

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

  MAUDE report 24583449 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L5/S1) FOR LUMBAR CANAL STENOSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES DELAY. SINCE THE PATIENT HAD NEUROLOGICAL SYMPTOMS CAUSED BY THE IMPLANTS AFTER SURGERY, AN REOPERATION WAS PERFORMED SUBSEQUENTLY. IN THE REOPERATION, 2 SCREWS IN QUESTION WERE REMOVED, NEW SCREWS WERE INSERTED WITH A CHANGE IN ENTRY POINT AND DIRECTION, AND RE-FIXATION WAS PERFORMED. AS THERE ARE NO SCREWDRIVERS THAT CAN APPLY TO VIPER PRIME SCREWS AFTER BREAKING OF THEIR TABS, NEW SCREWS WERE INSERTED AFTER REMOVING THE SCREWS IN QUESTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 21123255 ↗
• MalfunctionJul 19, 2022Device Slipped; Material Deformation; Device Slipped; Material Deformation

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING TLIF FOR TREATING SPONDYLOLISTHESIS, WHEN THE SCREW IN QUESTION WAS INSERTED IN L5 LEFT, THE TIP OF THE GUIDEWIRE BECAME DEFORMED AND WAS NOT ABLE TO BE REMOVED FROM THE INCISION. DURING TROUBLESHOOTING, THE SCREW BECAME LOOSE. WHEN THE SCREW WAS REMOVED, IT WAS FOUND THAT THE TIP OF THE SCREW HAD BEEN DEFORMED. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT SCREW AFTER A DELAY OF 10 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS A VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 X 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15057170 ↗
• MalfunctionApr 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SPINAL FUSION (L3-5) FOR TREATING BURST FRACTURE OCCURRED ON (B)(6) 2022. THE SURGEON DID NOT SUCCEED IN FINAL SETSCREW TIGHTENING AT L4 RIGHT. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT WHICH RESULTED IN LESS THAN 30-MINUTE SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR VIPER PRIME SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14162366 ↗
• InjuryFeb 16, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON, (B)(6) 2021 THE PATIENT UNDERWENT THE PRIMARY PROCEDURE (FOREIGN OBJECT REMOVAL AND SPINAL FUSION) RANGING L2/3. AFTER THE CAGE WAS DEPLOYED, THE SCREWS WERE PERCUTANEOUSLY INSERTED. THE PATIENT FELL OVER TWICE, WHICH RESULTED IN SCREW LOOSENING AND THE CAGE WAS BACKED OUT. ALSO, THE PATIENT HAD SUFFERED FROM PARALYSIS IN THE LOWER LIMB(S). ON (B)(6) 2022 THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE CAGE AND THE SCREW. THIS REPORT IS FOR ONE (1) VIPER PRIME CFX XTAB 7X40MM TI. THIS IS REPORT 3 OF 4 FOR (B)(4).

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

  MAUDE report 13545905 ↗
• InjuryFeb 16, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON, (B)(6) 2021 THE PATIENT UNDERWENT THE PRIMARY PROCEDURE (FOREIGN OBJECT REMOVAL AND SPINAL FUSION) RANGING L2/3. AFTER THE CAGE WAS DEPLOYED, THE SCREWS WERE PERCUTANEOUSLY INSERTED. THE PATIENT FELL OVER TWICE, WHICH RESULTED IN SCREW LOOSENING AND THE CAGE WAS BACKED OUT. ALSO, THE PATIENT HAD SUFFERED FROM PARALYSIS IN THE LOWER LIMB(S). ON (B)(6) 2022 THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE CAGE AND THE SCREW. THIS REPORT IS FOR ONE (1) VIPER PRIME CFX XTAB 7X40MM TI. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 13545904 ↗
• InjuryFeb 16, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON, (B)(6) 2021 THE PATIENT UNDERWENT THE PRIMARY PROCEDURE (FOREIGN OBJECT REMOVAL AND SPINAL FUSION) RANGING L2/3. AFTER THE CAGE WAS DEPLOYED, THE SCREWS WERE PERCUTANEOUSLY INSERTED. THE PATIENT FELL OVER TWICE, WHICH RESULTED IN SCREW LOOSENING AND THE CAGE WAS BACKED OUT. ALSO, THE PATIENT HAD SUFFERED FROM PARALYSIS IN THE LOWER LIMB(S). ON (B)(6) 2022 THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE CAGE AND THE SCREW. THIS REPORT IS FOR ONE (1) VIPER PRIME CFX XTAB 7X40MM TI. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 13545899 ↗
• InjuryFeb 16, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON, (B)(6) 2021 THE PATIENT UNDERWENT THE PRIMARY PROCEDURE (FOREIGN OBJECT REMOVAL AND SPINAL FUSION) RANGING L2/3. AFTER THE CAGE WAS DEPLOYED, THE SCREWS WERE PERCUTANEOUSLY INSERTED. THE PATIENT FELL OVER TWICE, WHICH RESULTED IN SCREW LOOSENING AND THE CAGE WAS BACKED OUT. ALSO, THE PATIENT HAD SUFFERED FROM PARALYSIS IN THE LOWER LIMB(S). ON (B)(6) 2022 THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE CAGE AND THE SCREW. THIS REPORT IS FOR ONE (1) VIPER PRIME CFX XTAB 7X40MM TI. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 13545897 ↗
• MalfunctionMar 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PPS IN LATERAL POSITION AT L4-5 TREATING SPONDYLOLISTHESIS ON (B)(6) 2021. WHEN THE SURGEON INSERTED A SCREW ON THE VIPER PRIME, THE SCREW IDLY TURNED. THE SURGEON CONTINUED THE PROCEDURE WITH A REPLACEMENT STYLET AND SCREW. WHEN THE SURGEON EXPERIENCED DIFFICULTY APPLYING THE REPLACEMENT STYLET AND SCREW AGAINST THE BONE, THEY CHANGED THE SURGICAL TECHNIQUE TO J-PROBE+GUIDE WIRING AND COMPLETED INSERTION. THE PROCEDURE WAS COMPLETED WITH LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER PRIME CFX XTAB 7X40MM TI. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495299 ↗
• InjuryDec 5, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR PLIF ( POSTERIOR LUMBAR INTERBODY FUSION) AT L4-5 TREATING SPONDYLOLISTHESIS. DURING THE SURGERY, IT WAS FOUND THAT TWO SCREWS HAD COME OFF THE PEDICLE. THE LESION WAS DEPLOYED AGAIN, AND THE 1ST SCREW WAS REMOVED WITHOUT DIFFICULTY BUT DIFFICULT TO PICK UP THE 2ND SCREW. FINALLY, THE 2ND SCREW WAS REMOVED, AND THE SURGERY COMPLETED SUCCESSFULLY WITH 30 MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME CFX XTAB 7X40MM TI. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10952296 ↗
• InjuryDec 5, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR PLIF ( POSTERIOR LUMBAR INTERBODY FUSION) AT L4-5 TREATING SPONDYLOLISTHESIS. DURING THE SURGERY, IT WAS FOUND THAT TWO SCREWS HAD COME OFF THE PEDICLE. THE LESION WAS DEPLOYED AGAIN, AND THE 1ST SCREW WAS REMOVED WITHOUT DIFFICULTY BUT DIFFICULT TO PICK UP THE 2ND SCREW. FINALLY, THE 2ND SCREW WAS REMOVED, AND THE SURGERY COMPLETED SUCCESSFULLY WITH 30 MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME CFX XTAB 7X40MM TI. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10952108 ↗
• MalfunctionJun 17, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) IN THE L4 RIGHT TREATING LUMBAR SPINAL CANAL STENOSIS THAT AFTER THE SCREW (186770340S) WAS INSERTED, A ROD AND A SETSCREW WERE DEPLOYED. THE SCREW HAD COME OFF THE PEDICLE AND THE SCREWHEAD CAME OFF THE REST OF THE SCREW SECTION. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. CONCOMITANT DEVICES: UNKNOWN SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) VIPER PRIME CFX XTAB 7X40MM TI. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10164128 ↗