VIPER 286735100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034214504), received between Apr 16, 2018 and Aug 24, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2023Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON(B)(6) 2023, AT THE TIME OF ASSEMBLING THE BAR IN THE BAR HOLDER, IT WAS EVIDENT THAT IT NEEDED THE INTERNAL SCREW THAT TIGHTENS THE BAR; HOWEVER, THE FOUR ADDITIONAL BAR HOLDERS IN THE EQUIPMENT DID NOT HAVE THE INTERNAL SCREW, AND THEREFORE THEY COULD NOT BE USED. THE SURGEON SOUGHT A SOLUTION TO BE ABLE TO PLACE THE BAR, AND WAS ABLE TO COMPLETE THE SURGERY IN AN APPROPRIATE WAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF ONE HOUR. THIS REPORT INVOLVES ONE VIPER 2 SYSTEM ROD HOLDER, ANGLED. THIS IS REPORT 4 OF 5 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610263 ↗
• MalfunctionAug 21, 2023Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AT THE TIME OF ASSEMBLE THE BAR IN THE BAR HOLDER EVIDENCED THAT IT NEEDS THE INTERNAL SCREW THAT TIGHTENS THE BAR HOWEVER INSIDE THE TEAM I HAVE 4 MORE BAR HOLDER, BUT NONE OF THE AVAILABLE CABLE CARRIERS HAD THE INTERNAL SCREW AND THEREFORE COULD NOT BE USED, HE WARNED THE SURGEON AND AT THAT TIME HE SOUGHT A SOLUTION TO BE ABLE TO PLACE THE BAR. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ONE(1) HOUR OF SURGICAL DELAY. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM ROD HOLDER, ANGLED. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583589 ↗
• MalfunctionSep 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT IN THE MIDDLE OF A SPINAL FUSION PROCEDURE ON (B)(6) 2022, WHILE TRYING TO LOAD A VIPER ROD ONTO A VIPER 2 ROD HOLDER, THE ROD WOULD NOT FIT OR ENGAGE. UPON CLOSER EXAMINATION FROM THE NURSE, IT APPEARED THAT THERE WAS A METAL PIECE APART OF THE ROD HOLDERS MECHANISM PROTRUDING AND INTERFERING. THE NURSE USED A HOSPITAL INSTRUMENT TO MOVE THE PROTRUSION AND WAS ABLE TO LOAD THE ROD AS INTENDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A SURGICAL DELAY OF 5 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER 2 SYSTEM ROD HOLDER, ANGLED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15358585 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT THE SURGEON HAD A VERY DIFFICULT CASE WITH A PATIENT WHO HAD VERY HARD BONE. THE SURGEON CHOSE NOT TO TAP THE BONE PRIOR TO SCREW INSERTION WHICH RESULTED IN HIGHER THAN NORMAL BONE/SCREW INSERTION TORQUE. THIS RESULTED IN SCREW DRIVER TIP BREAKAGE. SECONDARILY, THE SURGEON WAS TRYING TO PASS A ROD WITH A SEVERE BEND UP THE SPINE FROM THE PELVIS UP TO T10. AFTER PUTTING A VERY LORDOTIC BEND INTO THE ROD WHILE ATTACHED TO THE ROD HOLDER, HE THEN PUT A LOT OF FORCE ON THE ROD/ROD HOLDER INTERFACE WHILE PASSING UP THE SPINE. PATIENT CONSEQUENCE? : NO. 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 8089304 ↗
• MalfunctionMay 24, 2018Break; Break

  SURGEON ATTEMPTED TO RECONNECT THE ROD ONTO A NEW ROD HOLDER (ONE HAD PREVIOUSLY BROKEN) AND PUSH THE ROD UP THE SPINE WHILE LEVERAGING DOWN ONTO THE ROD HOLDER TO RAISE THE TIP OF THE ROD. THE ROD HOLDER SNAPPED AGAIN. PATIENT CONSEQUENCE? : NO. 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 7540607 ↗
• MalfunctionMay 24, 2018Break; Break

  SURGEON ATTEMPTED TO RECONNECT THE ROD ONTO A NEW ROD HOLDER (ONE HAD PREVIOUSLY BROKEN) AND PUSH THE ROD UP THE SPINE WHILE LEVERAGING DOWN ONTO THE ROD HOLDER TO RAISE THE TIP OF THE ROD. THE ROD HOLDER SNAPPED AGAIN. PATIENT CONSEQUENCE? NO. 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 7540325 ↗
• MalfunctionMay 23, 2018Break; Break

  SURGEON WAS PASSING THE ROD UP FROM THE PELVIS TO T10 AND WAS LEVERAGING ON THE ROD HOLDER IN ORDER TO PULL THE ROD UP. THE ROD HOLDER BROKE AT THE CONNECTION TO THE ROD. PATIENT CONSEQUENCE? NO. 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 7538299 ↗
• MalfunctionMay 18, 2018Break; Break

  MIS POLY DRIVER TIP BROKE WHEN INSERTING ILIAC SCREW, SURGEON TAPPED 7.0 AND WAS INSERTING 7.5X80MM SCREW, HE WAS ABLE TO KEEP THE SCREW INSIDE THE PATIENT AND FINISH. THE ROD HOLDER BROKE WHEN PASSING THE ROD. PASSING ROD FROM ILIAC UP TO T10, SKIPPED LEVELS THOUGH PATIENT CONSEQUENCE? : NO. 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 7526553 ↗
• MalfunctionApr 19, 2018Break; Break

  WHILE PASSING THE ROD FROM THE PELVIS UP TO T10, THE SURGEON WAS PUTTING DOWNWARD PRESSURE ON THE ROD HOLDER IN ORDER TO ELEVATE THE TIP OF THE ROD. THE ROD HOLDER FRACTURED AT THE JUNCTION OF THE ROD/ROD HOLDER INTERFACE. PATIENT CONSEQUENCE? NO. 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 7443470 ↗
• MalfunctionApr 16, 2018Break; Break

  IT WAS REPORTED INSTRUMENT TIPS BROKE INTRA-OP. TEN MINUTE DELAY REPORTED. NO ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7433043 ↗
• MalfunctionApr 16, 2018Break; Break

  IT WAS REPORTED INSTRUMENT TIPS BROKE INTRA-OP. TEN MINUTE DELAY REPORTED. NO ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7433022 ↗