VIPER 179704870Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034265704), received between Jun 19, 2020 and Nov 6, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 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.

• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT THE REOPERATION ON (B)(6) 2023 WITH L3-S SCREW REMOVAL, L2/3 TLIF (NON-JJ PRODUCT: TRITANIUM), L2-SAI SCREW INSERTION (JJ PRODUCTS: VERSEFS, EXPEDIUM DI, AND EXPEDIUM SAI). ON (B)(6) 2025, A L1/2 TLIF WAS PERFORMED DUE TO ADJACENT SEGMENT DYSFUNCTION. L2 TO SAI WERE LEFT AS IS. VERSEFS (1.8CC CEMENT EACH) WAS USED FOR L1, AND RISE (GLOBUS) WAS USED FOR L1/2. CRANK RODS (NUVASIVE) AND ROD CONNECTORS WERE USED TO CONNECT TO THE EXISTING RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SALES REP RECEIVED A COMPLAINT AFTER A CT SCAN ON (B)(6) 2025, SHOWED BILATERAL BREAKAGE OF THE L1 SCREW IN A PATIENT WHO UNDERWENT L1/2 TLIF (VERSEFS + RISE (GLOBUS). THE SCREW BROKE NEAR THE LATERAL HOLE OF THE SCREW. IT IS CURRENTLY UNDECIDED WHETHER OR NOT TO PERFORM SURGERY ON THIS PATIENT IN THE FUTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT AND (B)(4) REPORTS THE REVISION SURGERY PERFORMED ON (B)(6) 2025 WHILE RELATED (B)(4) REPORTS THE BREAKAGE OF THE SCREW OCCURRED AFTER THE SURGERY PERFORMED ON (B)(6) 2025.

  Patient problems: Osteolysis

  MAUDE report 23491036 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT THE REOPERATION ON (B)(6) 2023 WITH L3-S SCREW REMOVAL, L2/3 TLIF (NON-JJ PRODUCT: TRITANIUM), L2-SAI SCREW INSERTION (JJ PRODUCTS: VERSEFS, EXPEDIUM DI, AND EXPEDIUM SAI). ON (B)(6) 2025, A L1/2 TLIF WAS PERFORMED DUE TO ADJACENT SEGMENT DYSFUNCTION. L2 TO SAI WERE LEFT AS IS. VERSEFS (1.8CC CEMENT EACH) WAS USED FOR L1, AND RISE (GLOBUS) WAS USED FOR L1/2. CRANK RODS (NUVASIVE) AND ROD CONNECTORS WERE USED TO CONNECT TO THE EXISTING RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SALES REP RECEIVED A COMPLAINT AFTER A CT SCAN ON (B)(6) 2025, SHOWED BILATERAL BREAKAGE OF THE L1 SCREW IN A PATIENT WHO UNDERWENT L1/2 TLIF (VERSEFS + RISE (GLOBUS). THE SCREW BROKE NEAR THE LATERAL HOLE OF THE SCREW. IT IS CURRENTLY UNDECIDED WHETHER OR NOT TO PERFORM SURGERY ON THIS PATIENT IN THE FUTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT AND (B)(4) REPORTS THE REVISION SURGERY PERFORMED ON (B)(6) 2025 WHILE RELATED (B)(4) REPORTS THE BREAKAGE OF THE SCREW OCCURRED AFTER THE SURGERY PERFORMED ON (B)(6) 2025.

  Patient problems: Osteolysis

  MAUDE report 23490958 ↗
• InjuryMar 25, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ON (B)(6) 2020 THE PATIENT UNDERWENT THE PRIMARY PROCEDURE IN THE SACRUM AND THE ILIUM FOR TREATING ASD WITH THE SCREWS IN QUESTION THAT WERE INSERTED FROM THE SACRUM INTO THE ILIUM AND DEPLOYED ON BOTH SIDES. THE SCREWS IN QUESTION WERE SUPPOSED TO FUNCTION AS ANCHORS FOR CORRECTING THE PELVIS. ON AN UNKNOWN DATE IT WAS FOUND THAT THE SCREWS HAD COME OFF. A SETSCREW HAD COME OFF THE SCREW, AND A ROD HAD COME OFF THE SCREW ON ONE SIDE. ON THE OTHER SIDE, A SETSCREW HAD BEEN TIGHTENED TO THE SCREW, BUT THE ROD HAD COME OFF THE SCREW. THE PATIENT IS SCHEDULED TO UNDERGO A REMOVAL PROCEDURE IN THE 1ST WEEK OF (B)(6) 2022. THIS REPORT IS FOR ONE (1) VIPER TI SAI POLY 8X70MM. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

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

  MAUDE report 13907200 ↗
• InjuryMar 25, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, ON (B)(6) 2020 THE PATIENT UNDERWENT THE PRIMARY PROCEDURE IN THE SACRUM AND THE ILIUM FOR TREATING ASD WITH THE SCREWS IN QUESTION THAT WERE INSERTED FROM THE SACRUM INTO THE ILIUM AND DEPLOYED ON BOTH SIDES. THE SCREWS IN QUESTION WERE SUPPOSED TO FUNCTION AS ANCHORS FOR CORRECTING THE PELVIS. ON AN UNKNOWN DATE IT WAS FOUND THAT THE SCREWS HAD COME OFF. A SETSCREW HAD COME OFF THE SCREW, AND A ROD HAD COME OFF THE SCREW ON ONE SIDE. ON THE OTHER SIDE, A SETSCREW HAD BEEN TIGHTENED TO THE SCREW, BUT THE ROD HAD COME OFF THE SCREW. THE PATIENT IS SCHEDULED TO UNDERGO A REMOVAL PROCEDURE IN THE 1ST WEEK OF (B)(6) 2022. THIS REPORT IS FOR ONE (1) VIPER TI SAI POLY 8X70MM. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

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

  MAUDE report 13907183 ↗
• InjuryJun 19, 2020No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2015, AN INITIAL SPINAL FUSION WAS PERFORMED FOR KYPHOSIS. THE PROCEDURE WAS FOR BUILDING CONSTRUCT IN T9-S2. ON (B)(6) 2015, A SECOND PROCEDURE WAS PERFORMED FOR OSTEOTOMY IN L1 AND RE-DEPLOYING THE DEVICES STRYKER¿S CONNECTOR AND ROD WHICH WERE IMPLANTED IN THE INITIAL PROCEDURE. THE IMPLANTED ROD WAS CONNECTED TO THE STRYKER¿S CONNECTOR. ON (B)(6) 2018, THE REVISION PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. THE SURGEON EXPLANTED TWO (2) UNKNOWN EXPEDIUM SCREWS IN S1 AND REPLACED THEM WITH UNKNOWN SCREWS. ALSO, ONE (1) SCREW WAS REPLACED IN S2 LEFT, S2 RIGHT. ONE (1) ROD WAS EXPLANTED AND REPLACED WITH TWO (2) RODS CONNECTED TO THE STRYKER¿S CONNECTOR. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); VIPER TI SAI POLY 8X70MM (PART# 179704870, LOT# UNKNOWN, QUANTITY 1); ROD, 480 MM (PART# 179762480, LOT# UNKNOWN, QUANTITY 1); UNKNOWN LOCKING/SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT IS RELATED TO (B)(4) WHICH INVOLVES FOUR TOTAL PROCEDURES ((B)(6) 2015, (B)(6) 2015

  Patient problems: Injury

  MAUDE report 10176443 ↗
• InjuryJun 19, 2020No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2015, AN INITIAL SPINAL FUSION WAS PERFORMED FOR KYPHOSIS. THE PROCEDURE WAS FOR BUILDING CONSTRUCT IN T9-S2. ON (B)(6) 2015, A SECOND PROCEDURE WAS PERFORMED FOR OSTEOTOMY IN L1 AND RE-DEPLOYING THE DEVICES STRYKER¿S CONNECTOR AND ROD WHICH WERE IMPLANTED IN THE INITIAL PROCEDURE. THE IMPLANTED ROD WAS CONNECTED TO THE STRYKER¿S CONNECTOR. ON (B)(6) 2018, THE REVISION PROCEDURE WAS PERFORMED FOR AN UNKNOWN REASON. THE SURGEON EXPLANTED TWO (2) UNKNOWN EXPEDIUM SCREWS IN S1 AND REPLACED THEM WITH UNKNOWN SCREWS. ALSO, ONE (1) SCREW WAS REPLACED IN S2 LEFT, S2 RIGHT. ONE (1) ROD WAS EXPLANTED AND REPLACED WITH TWO (2) RODS CONNECTED TO THE STRYKER¿S CONNECTOR. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), VIPER TI SAI POLY 8X70MM (PART# 179704870, LOT# UNKNOWN, QUANTITY 1); ROD, 480 MM (PART# 179762480, LOT# UNKNOWN, QUANTITY 1); UNKNOWN LOCKING/SET SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT IS RELATED TO (B)(4) WHICH INVOLVES FOUR TOTAL PROCEDURES ((B)(6) 2015, (B)(6) 2015

  Patient problems: Injury

  MAUDE report 10174209 ↗