VIPER 186770150Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034465807), received between Aug 3, 2017 and Oct 3, 2023 — classified as 4 injuries, 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 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 A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L4/5) WAS PERFORMED ON (B)(6), 2018. AFTER THE INITIAL SURGERY, ADJACENT SEGMENT DISEASE OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6), 2023. THIS REPORT INVOLVES ONE VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 50MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS DIFFICULTIES ENCOUNTERED IN THE REVISION SURGERY. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE RODS INVOLVED IN THE EVENT. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 17862353 ↗
• InjuryOct 3, 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 A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L4/5) WAS PERFORMED ON (B)(6), 2018. AFTER THE INITIAL SURGERY, ADJACENT SEGMENT DISEASE OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6), 2023. THIS REPORT INVOLVES ONE VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 50MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS DIFFICULTIES ENCOUNTERED IN THE REVISION SURGERY. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE RODS INVOLVED IN THE EVENT. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 17862165 ↗
• InjuryOct 3, 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 A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L4/5) WAS PERFORMED ON (B)(6) 2018. AFTER THE INITIAL SURGERY, ADJACENT SEGMENT DISEASE OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THIS REPORT INVOLVES ONE VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 50MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS DIFFICULTIES ENCOUNTERED IN THE REVISION SURGERY. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE RODS INVOLVED IN THE EVENT. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 17862141 ↗
• InjuryOct 3, 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 A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L4/5) WAS PERFORMED ON (B)(6) 2018. AFTER THE INITIAL SURGERY, ADJACENT SEGMENT DISEASE OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023.THIS REPORT INVOLVES ONE VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 7.0MM X 50MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS DIFFICULTIES ENCOUNTERED IN THE REVISION SURGERY.THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE RODS INVOLVED IN THE EVENT.THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 17862074 ↗
• MalfunctionMay 17, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION FOR SPINAL STENOSIS ON (B)(6) 2023. THE TAB OF THE SCREW BROKE BEFORE THE TORQUE WRENCH IDLED. THE SURGEON ATTEMPTED FINAL TIGHTENING OF ANOTHER SCREW WITH THE TORQUE WRENCH, BUT THE TORQUE WRENCH DID NOT IDLE EVEN THOUGH THE SURGEON TIGHTENED QUITE FIRMLY, AND IT SEEMED LIKE THE TORQUE WRENCH WAS ABOUT TO BREAK. THERE WAS NO SUBSTITUTE FOR THE TORQUE WRENCH WHICH WAS READY TO USE AT THE SURGERY. THEREFORE, THE SALES REP SUGGESTED THAT THE SURGEON STOP THE TIGHTENING OF A SET SCREW WHEN THE SURGEON FELT THAT THE SET SCREW WAS SUFFICIENTLY TIGHTENED, BECAUSE THERE WAS A RISK OF IMPLANT DAMAGE IF THE TORQUE WRENCH WAS ROTATED UNTIL IT IDLED. THE SALES REP COULD TELL FROM THE WAY THE SURGEON APPLIED PROPER FORCE AND THE SOUND EMITTED FROM THE TORQUE WRENCH THAT THE SURGEON HAD PERFORMED A SUFFICIENT TIGHTENING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT STATUS/OUTCOME IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) (B)(4). THIS IS REPORT 2 OF 2 FOR COMPLAINT VIPER2 FINAL TIGHTENER HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945132 ↗
• MalfunctionAug 30, 2017Break; Break

  ON (B)(6) 2017, SURGERY FOR SPINAL CANAL STENOSIS WAS PERFORMED USING THE X-TAB SYSTEM. THE FIXED AREA WAS L3 ¿ L4. DURING THE SURGERY, THE SURGEON FACED THE FOLLOWING DIFFICULTIES AND COMPLETED THE SURGERY SUCCESSFULLY. THE PATIENT¿S BONES WERE SO HARDENED AND THE PEDICLE AREAS AS WELL. THE SURGEON MANAGED TO INSERT X-TAB (PART#: 186770150, LOT#: UNK) AT L3 AND L4 USING A T-HANDLE, HOWEVER, THE LENGTH OF EACH TAB WAS DIFFERENT. TO ADJUST THE LENGTH OF EACH TAB, THE SURGEON TRIED TO INSERT IT AGAIN BY USING DRIVER (PART# & LOT#: UNK) AND WRENCH FOR FINAL TIGHTENING (PART# & LOT#: UNK), AND THEN ONE TAB OF X-TAB GOT BROKEN DUE TO HARDENED BONES. THE SURGEON SUCCESSFULLY INSERTED IT AND ADJUST ITS LENGTH BY USING THE VIPER EXTENDER AND VBD INSTRUMENT SET. THE X-TAB WAS USED BECAUSE TAB WAS BROKEN PROPERLY. NO BROKEN PARTS WERE FOUND LEFT IN THE BODY, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A 10-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6831549 ↗
• MalfunctionAug 3, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  UPON INSERTION OF THE VIPER CORTICAL FIX XTAB SCREW (7X50) THE HEAD BROKE FREE FROM THE SCREW. WE NOTED ON THE XRAY THAT THE SCREW WAS NOT FULLY SEATED IN BONE OR WEDGED BETWEEN THE FACET HOWEVER THE SCREW SHANK WENT THROUGH THE BOTTOM OF THE TULIP HEAD. THE SADDLE REMAINED INSIDE THE SCREW HEAD AND THE SCREW WAS REMOVED WITHOUT INCIDENT USING THE STANDARD SCREWDRIVER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6764898 ↗