VIPER 286705220Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034213682), received between Apr 2, 2018 and May 6, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A POSTERIOR FIXATION PERFORMED ON AN UNKNOWN DATE. WHEN A PVP AND A POSTERIOR FIXATION WERE PERFORMED, THE STENT OF THE VBS WAS RETAINED IN THE BODY, AND THE GUIDE WIRE WAS INSERTED AFTER THE CEMENT WAS INJECTED. DURING THE SCREW INSERTION THROUGH THE GUIDE WIRE, THE CEMENT HAD ALREADY HARDENED OVER TIME, AND THE GUIDE WIRE COULD NOT BE REMOVED SMOOTHLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. THE SURGEON SAID THAT IT WAS NEEDED TO BE MORE CAREFUL IN THE FUTURE AND PROCEED OPERATION IN COOPERATION WITH ENGINEER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092906 ↗
• MalfunctionJan 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A VBS PERFORMED ON (B)(6) 2025, VIPERPRIME WAS USED FOR VBS AND POSTERIOR FIXATION. AFTER VBS WAS PERFORMED, THE GUIDE WIRE WAS INSERTED WHEN INSERTING A SCREW INTO THE SAME VERTEBRAL BODY. AFTER INSERTING A SCREW OVER THE GUIDE WIRE, THE CEMENT ADHERED WHEN THE GUIDE WIRE WAS REMOVED, MAKING IT DIFFICULT TO REMOVE. WHEN THE SURGEON TRIED TO REMOVE IT, THE VBS FILLED WITH CEMENT WAS BACKED OUT. THIS OCCURRED ON THE LEFT SIDE. THE RIGHT SIDE WAS COMPLETED WITHOUT INCIDENT. VBS WAS PERFORMED AGAIN DURING RECOVERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF SURGICAL DELAY. UPON CHECKING, THERE WAS NO IMPACT TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055641 ↗
• MalfunctionJul 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE SURGERY, THE SURGEON APPROACHED THE VERTEBRAL BODY WITH A PROBE AND PASSED A GUIDE WIRE THROUGH THE HOLLOW PART, BUT THEN HAD DIFFICULTY REMOVING THE PROBE FROM THE BODY. BECAUSE NO DEFORMATION WAS NOTED IN THE GUIDE WIRE OR PROBE, IT WAS SUSPECTED THAT THE DIAMETER OF THE GUIDE WIRE MAY HAVE BEEN LARGER THAN THE SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387257 ↗
• MalfunctionApr 1, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR SPINAL FUSION ON (B)(6) 2025. DURING SCREW INSERTION, A PIECE OF THE GUIDE-WIRE BROKE UNDER THE SCREW AND REMAINED IN THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO ADDITIONAL INTERVENTION. PATIENT OUTCOME WAS POSITIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21741428 ↗
• MalfunctionDec 11, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THIS WAS PVP AND PLF (L3) PERFORMED ON (B)(6) 2024. DURING THE SURGERY, AN UNKNOWN DEFECT OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20903913 ↗
• MalfunctionOct 21, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE. THE DETAILS OF THE PRODUCTS USED IN THE INITIAL SURGERY ARE UNKNOWN. ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED TO RE-FIX THE LUMBAR SPINE FOR DEGENERATIVE LUMBAR SPONDYLOLISTHESIS. IN THE SURGERY, A SCREW WAS INSERTED OVER THE GUIDE WIRE. THE SURGEON ATTEMPTED TO REMOVE THE GUIDE WIRE AFTER INSERTING THE SCREW BUT WAS UNABLE TO DO SO. THE SURGEON THEREFORE BACKED OUT THE SCREW SLIGHTLY AND ATTEMPTED TO REMOVE THE GUIDE WIRE AGAIN. IN DOING SO, THE TIP OF THE GUIDE WIRE BROKE OFF AND REMAINED INSIDE THE PATIENT. THE BROKEN PORTION OF THE GUIDE WIRE WAS THEN REMOVED FROM THE PATIENT'S BODY UNDER IMAGING, AND ULTIMATELY NO FRAGMENTS WERE FOUND IN THE PATIENT'S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES SURGICAL DELAY. PATIENT WAS STABLE. THE SURGEON'S OPINION ON THE CAUSE OF THE BREAKAGE IS AS FOLLOWS. THE SCREW'S TRAJECTORY WAS MISALIGNED WITH THE TAPPED TRAJECTORY, AND AN ATTEMPT WAS MADE TO FORCIBLY REMOVE THE GUIDE WIRE WITH ITS DIRECTION BENT, WHICH LED TO THIS BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493172 ↗
• MalfunctionMay 23, 2024Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A VBS (TH12) FOR FRACTURE, FOR 1ABOVE1BELOW FUSION CASE, WHEN INSERTING A SCREW, THE GUIDEWIRE IN QUESTION WAS USED. THE CEMENT AND THE TIP OF THE GUIDEWIRE ADHERED, MAKING EXTRACTION DIFFICULT. THE PRIMARY SURGEON ATTEMPTED TO REMOVE THE CEMENT LUMP BY CUTTING IT OFF WITH THE TIP OF THE SCREW OR A TAP, BUT WAS UNABLE TO DO SO, SO THE 4 CM TIP OF THE GUIDEWIRE WAS CUT WITH A HOSPITAL INSTRUMENT AND THE RELEVANT PORTION WAS LEFT IN THE HOLLOW OF THE SCREW. THE CUT GUIDEWIRE WAS SANDWICHED BETWEEN THE VBS CEMENT MASS AND THE ROD AND WAS DETERMINED NOT TO MOVE WITHIN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. THE SURGEON COMMENTED THAT THE GUIDEWIRE WAS INSERTED INTO THE CEMENT MASS FOR A CERTAIN AMOUNT OF TIME, WHICH WAS THE CAUSE OF THIS EVENT. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM GUIDEWIRE, BLUNT AND DISPOSABLE 1.45MM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES THE CEMENT INVOLVED IN THE INCIDENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19380459 ↗
• MalfunctionMar 12, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAFF COULD NOT THREAD THE GUIDE WIRE DOWN BACK OF TWO VIPER TAPS AS THERE WAS SOMETHING BLOCKING GUIDE WIRE FROM FUNNELING DOWN. THE SURGEON TRIED DIFFERENT GUIDEWIRES (X2) AND HANDLES AND THOSE WERE NOT THE ISSUE. THE GUIDE WIRES SNAPPED AFTER TRYING TO GET THEM THROUGH TAP. FINALLY THE THIRD TAP WAS TRIED AND WORKED WELL. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE VIPER2 1.45 DIA GUIDEWIRE, BLU. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885381 ↗
• MalfunctionMar 12, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAFF COULD NOT THREAD THE GUIDE WIRE DOWN BACK OF TWO VIPER TAPS AS THERE WAS SOMETHING BLOCKING GUIDE WIRE FROM FUNNELING DOWN. THE SURGEON TRIED DIFFERENT GUIDEWIRES (X2) AND HANDLES AND THOSE WERE NOT THE ISSUE. THE GUIDE WIRES SNAPPED AFTER TRYING TO GET THEM THROUGH TAP. FINALLY THE THIRD TAP WAS TRIED AND WORKED WELL. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) VIPER2 1.45 DIA GUIDEWIRE, BLU THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885281 ↗
• InjuryMar 6, 2023Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION AND A PERCUTANEOUS VERTEBROPLASTY (TH12) FOR THE 12TH THORACIC COMPRESSION FRACTURE ON (B)(6) 2023. THE EVENT TOOK PLACE IN SEQUENCE AS FOLLOWS: THE EXPEDIUM VERSE FENESTRATED SCREWS WERE INSERTED INTO TH10, TH11, L1, AND L2. THEN, CEMENT AUGMENTATION WAS PERFORMED. AFTER CEMENT AUGMENTATION, A BKP WAS PERFORMED WITH SYNFLATE AT TH12. BOTH SIDE OF BALLOONS WERE INFLATED UP TO 4.0 ML. 3.7 CC OF THE CEMENT WAS INJECTED ON TH12 RIGHT, AND 3.8 CC OF THE CEMENT WAS INJECTED ON TH12 LEFT. AT THE END OF CEMENT INJECTION, 12 MINUTES HAVE ELAPSED SINCE THE START OF CEMENT MIXING. THE CEMENT NEEDLE AND THE SLEEVE WERE REMOVED. THE GUIDE WIRE WAS INJECTED, AND THEN THE SCREWS WERE IMMEDIATELY INJECTED WITHOUT TAP. ALTHOUGH THE SCREWS WERE INSERTED ON BOTH SIDES, RIGHT SIDE OF THE GUIDE WIRE COULD NOT BE REMOVED BECAUSE OF CEMENT HARDENING. AT THIS POINT, 15 MINUTES AND 30 SECONDS HAVE ELAPSED SINCE THE START OF CEMENT MIXING. THE SCREW WAS REMOVED BECAUSE THE GUIDE WIRE COULD NOT BE REMOVED. THE GUIDE WIRE WAS CUT BY THE PIN CUTTER. APPROXIMATELY 3 TO 4 CM OF THE GUIDE WIRE REMAIN

  Patient problems: Foreign Body In Patient

  MAUDE report 16484996 ↗
• InjuryFeb 17, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 A PPS (L4) FOR LUMBAR DEGENERATIVE DISEASE WAS BEING PERFORMED. THE GUIDE WIRE WAS INSERTED THROUGH J-PROBE, AND DEPTH WAS ADJUSTED USING PLIERS AND A HAMMER. WHEN THE GUIDE WIRE WAS REMOVED, THE TIP WAS BROKEN. THE IMAGE SHOWED THAT APPROXIMATELY 2 MM OF THE BROKEN TIP REMAINED IN THE VERTEBRAL BODY. THE SURGEON DETERMINED THAT IT WAS DIFFICULT TO REMOVE AND THERE WOULD BE NO IMMEDIATE IMPACT ON THE PATIENT. THEN, THE WOUND WAS CLOSED WITH THE BROKEN TIP LEFT INSIDE THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR A VIPER SYSTEM GUIDEWIRE, BLUNT AND DISPOSABLE 1.45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16397932 ↗
• InjuryAug 6, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR AN UNKNOWN SURGERY. DURING THE SURGERY, WHEN THE SCREW INSERTION WAS CHECKED WITH THE C-ARM, THE CHIPPED GUIDE WIRE (ABOUT 5 MM LONG) WAS FOUND NEAR THE SCREW TIP. WHEN THE REMOVED GUIDE WIRE WAS CHECKED, IT WAS CONFIRMED THAT THE GUIDE WIRE'S TIP HAD BEEN BROKE AND LOST. THE SURGEON DECIDED TO LEAVE THE FRAGMENT IN THE PATIENT'S BODY AND COMPLETED THE PROCEDURE. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) VIPER2 1.45 DIA GUIDEWIRE, BLU. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10376255 ↗
• MalfunctionOct 29, 2018Break; Break

  IT WAS REPORTED DOCTOR WAS PERFORMING A MIS LUMBOPELVIC STABILIZATION PROCEDURE FOR A TRAUMATIC SACRAL FRACTURE. HE DID THIS ON (B)(6) 2018 AND USED VIPER PRIME FOR THE L5 SCREW AND A VIPER SAI FULLY THREADED SCREW FOR THE ILIUM. THE CONSTRUCT WAS A UNILATERAL PROCEDURE AND WAS ON THE RIGHT SIDE. DOCTOR USED "JAMSHIDI" NEEDLES TO CREATE THE TRACTS FOR HIS SCREWS. HE THEN INSERTED 286705220 GUIDEWIRES AND REMOVED THE JAMSHIDI NEEDLES. HE PLACED THE L5 VIPER PRIME SCREW WITHOUT INCIDENT. HE THEN TAPPED THE ILIAC SCREW AND THEN PLACED THE VIPER SAI SCREW. ONCE THE SCREW WAS PLACED WHERE HE WANTED, HE THEN ATTEMPTED TO REMOVE THE GUIDWIRE. THE GUIDEWIRE WOULD NOT MOVE. HE USED VARIOUS STYLES OF FORCEPS FROM THE ACCOUNT GENERAL SPINE INSTRUMENTS. NOTHING WOULD WORK. HE THEN ASKED FOR A BATTERY POWERED DRILL AND USED A WIRE DRIVER AND PLACED IT ON THE "STUCK" WIRE. HE THEN USED THE DRILL TO ROTATE THE GUIDEWIRE AND PULLED. AFTER 10-15 SECONDS, THE WIRE CAME OUT, BUT ABOUT 8MM OF THE DISTAL TIP BROKE OFF. IT APPEARED AS THOUGH THE BROKEN PART OF THE WIRE WAS IN THE CANNULATION OF THE SCREW. DOCTOR ELECTED TO LEAVE THE SCREW IN PLACE. HE THEN SUCCESSFULLY COMPLETED THE PROCEDURE. SURGICAL

  Patient problems: Foreign Body In Patient

  MAUDE report 8016034 ↗
• MalfunctionApr 16, 2018Break; Break

  TIP OF THE GUIDING WIRE BROKE OFF (2CM APPROX.) INTRA-OP, DURING REMOVAL - IT REMAINED INSIDE VERTEBRAL BODY.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7432531 ↗
• MalfunctionApr 9, 2018Break; Break

  SURGEON: MR (B)(6). HOSPITAL TOWN: (B)(6). PRODUCT NAME: VIPER 2 GUIDEWIRE. PRODUCT CODE : 286705220 WHEN INSERTING VIPER SAI SCREW (179704880). LOT/BATCH/EXP: NOT KNOWN. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. EVENT OUTCOME/HOW WAS IT MANAGED? THE GUIDE WIRE HAD BEEN REMOVED. THE SURGEONS CHECKED THE X RAYS AND CONFIRMED NO ACTION WOULD BE TAKEN. WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE EXTENDED GREATER THAN 30 MINUTES DUE TO THE FAILURE? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? NO DISPOSED OF IN SHARPS BIN. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: UPON INSERTION OF THE SAI SCREW AND SUBSEQUENT REMOVAL OF THE GUIDE WIRE. THE TIP OF THE GUIDEWIRE (~5 MM) SNAPPED REMAINING IN THE PATIENTS BONE. WHEN FIRST REMOVED THE GUIDEWIRE APPEARED SLIGHTLY BENT FOLLOWING SCREW INSERTION, BUT THIS DIDN¿T CONCERN MR (B)(6). THE PROCEDURE CONTINUED (INSERTION OF SAI SCREWS AND 2 NEW RODS WITH UNIVERSAL CONNECTOR TO CONNECT TO EXISTING CONSTRUCT T12 SACRUM) AND UPON TAKING THE FINAL AP TO IMAGE IT WAS NOT

  Patient problems: Foreign Body In Patient

  MAUDE report 7409921 ↗
• MalfunctionApr 2, 2018Break; Break

  ON (B)(6) 2014, THE SURGERY FOR KYPHOSCOLIOSIS WAS PERFORMED BY USING THE VIPER SYSTEM. IN ORDER TO INSERT THE SAI SCREW, THE GUIDE WIRE WAS INSERTED FROM THE SACRUM TO THE ILIAC. WHEN THE TAP WAS CUT OVER THE GUIDE WIRE, THE TIP OF THE GUIDE WIRE WAS BROKEN. A BROKEN PIECE WAS LEFT IN THE PATIENT. THE BROKEN PIECE WAS NOT REMOVABLE. NO FURTHER MEDICAL INTERVENTION IS PLANNED. THE SURGERY WAS COMPLETED WITH A DELAY (LESS THAN 30 MINUTES).

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 7390273 ↗