VIPER 179704990Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034265865), received between Aug 6, 2018 and Apr 22, 2022 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionApr 22, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY, WHEN ASSEMBLING SCREWS, THE INTERNAL THREAD WAS BROKEN AND DROPPED. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) VIPER TI SAI POLY 9X90MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187544 ↗
• InjuryMar 4, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT THE PRIMARY PROCEDURE AND THE VIPER POLYAXIAL SCREW WAS IMPLANTED AT S2. ON AN UNKNOWN POSTOPERATIVE DATE IT WAS FOUND THAT THE SCREW HAD BEEN LOOSE. THE PATIENT UNDERWENT A REVISION PROCEDURE FOR LOOSE SCREW REPLACEMENT ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS INCIDENT IS RELATED TO (B)(4) WHICH CAPTURES THE INTRAOPERATIVE SCREWDRIVERS BREAKAGES DURING THE REVISION PROCEDURE. THIS REPORT IS FOR ONE (1) VIPER TI SAI POLY 9X90MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 13668368 ↗
• MalfunctionFeb 11, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE DURING FINAL TIGHTENING OF THE SET SCREW THE VIPER SAI SCREW PARTIAL THREAD (9X90MM) HEAD SPLAYED. THE SURGEON HAD TO REMOVE THIS SCREW, AND REPLACE WITH A 10X90MM VIPER SAI SCREW, WHICH WAS THEN ABLE TO FINAL TIGHTEN. NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER TI SAI POLY 9X90MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515029 ↗
• InjuryAug 23, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A SURGERY FOR POSTERIOR SPINAL FUSION IN (B)(6) OF 2020. AT A FOLLOW UP APPOINTMENT IN (B)(6) OF 2020, XRAY IMAGES SHOWED THAT THE SET SCREW HAD LOOSENED FROM THE SAI SCREWS BILATERALLY AND THE ROD HAD LOOSENED DUE TO HEAD SPLAY. THE S1 AND L5 SCREWS HAD FRACTURED AT THE NECK OF THE SCREW JUST BELOW THE TULIP. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. THE PATIENT DID NOT ACHIEVE A FUSION BELOW L5 DUE TO THIS HARDWARE FAILURE. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) VIPER TI SAI POLY 9X90 MM. THIS REPORT IS 2 OF 5 FOR (B)(4).

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

  MAUDE report 12354202 ↗
• InjuryJul 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE ROD THAT WAS BROKEN BILATERALLY AND THE DISTAL SCREWS WERE LOOSENED. BROKEN ENDS OF ROD CATALOG # 1797-62-480, VERSE SCREW, 1997-21-750 X QTY 1, VERSE SCREW 1997-21-745 X QTY 1 AND 9.0X90MM SAI SCREWS 1797-04-990 X QTY 2 WERE ALL REMOVED TO REVISE. A 12.0X100MM SCREW, 1797-12-399 WAS REMOVED WITH PLIERS DUE TO THE FIRST OF TWO SCREWDRIVER TIPS BREAKING. THIS SCREW WAS NOT RECOVERED TO RETURN. THERE WERE NO FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WERE SURGICAL DELAY. THE PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8821962 ↗
• InjuryJul 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE ROD THAT WAS BROKEN BILATERALLY AND THE DISTAL SCREWS WERE LOOSENED. BROKEN ENDS OF ROD CATALOG # 1797-62-480, VERSE SCREW, 1997-21-750 X QTY 1, VERSE SCREW 1997-21-745 X QTY 1 AND 9.0X90MM SAI SCREWS 1797-04-990 X QTY 2 WERE ALL REMOVED TO REVISE. A 12.0X100MM SCREW, 1797-12-399 WAS REMOVED WITH PLIERS DUE TO THE FIRST OF TWO SCREWDRIVER TIPS BREAKING. THIS SCREW WAS NOT RECOVERED TO RETURN. THERE WERE NO FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WERE SURGICAL DELAY. THE PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8821841 ↗
• InjuryAug 6, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  SCREW WAS INSERTED WITH CORRECT SCREW DRIVER AND NO ISSUES. ROD WAS PLACED IN CONSTRUCT AND LOCKING CAPS WERE INSERTED. THE LOCKING CAPS FOR THE SAI SCREW COULD NOT BE TIGHTENED ALTHOUGH ROD SEEMED TO BE SEATING WELL IN SCREW HEAD. A SECOND LOCKING CAP WAS TAKEN TRYING AGAIN TO LOCK IT. THE IT WAS REALIZED THAT THE ISSUE WAS WITH THE SCREW AND NOT THE LOCKING CAP. ACCORDINGLY THE SCREW WAS REPLACED WITH A NEW ONE AND EVERYTHING COULD BE COMPLETED WITHOUT A PROBLEM. PATIENT CONSEQUENCE?: NO. ACTION TAKEN FOR PROCEDURE:NEW SCREW WAS INSERTED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7752082 ↗