VIPER 186731750Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705034352022), received between Aug 3, 2017 and Sep 24, 2024 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Break; Compatibility Problem; Break; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THIS WAS A TLIF (LUMBAR) FOR SPONDYLOLISTHESIS. DURING SURGERY, THE SET SCREW COULD NOT BE INSERTED INTO THE CORTICAL FIX SCREW DURING SET SCREW FASTENING. THEREFORE, THE CORTICAL FIX SCREW WAS REMOVED, ANOTHER SCREW WAS INSERTED INTO THE SET SCREW, AND THE SURGERY WAS COMPLETED. THE SURGEON ATTEMPTED TO INSERT A SET SCREW INTO THE CORTICAL FIX SCREW EVEN OUTSIDE THE PATIENT'S BODY BUT WAS UNABLE TO DO SO. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292129 ↗
• InjuryJan 29, 2024Adverse 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 THIS WAS AN ORIGINAL UNKNOWN SURGERY OCCURRED ON (B)(6), 2020. POST-OPERATIVELY ON AN UNKNOWN DATE, ADJACENT SEGMENT DISEASE (ASD) OCCURRED. A REVISION SURGERY OCCURRED TO EXTEND FIXATION AND REMOVE HARDWARE ON (B)(6), 2023. THE SFX CROSS-LINK WAS REMOVED. SET SCREW AND ROD WERE REMOVED. OF THE SCREWS IN L3-5, ONLY L3 AND L4 SCREWS WERE REMOVED. (BONE FUSION WAS COMPLETED) L5 SCREW WERE PRESERVED. S ADDITIONAL SCREW OF 7.0-45MM DIAMETER WAS INSERTED. L5-S TLIF WAS PERFORMED.(CAGE WAS OTHER COMPANY¿S PRODUCT.) SFX CROSS-LINK WAS PLACED, AND THE FINAL TIGHTENING WAS DONE. THIS REPORT IS FOR ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 50MM FOR (B)(4). (B)(4) ARE LINKED. ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED FOR THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 18597209 ↗
• InjuryJan 29, 2024Adverse 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 THIS WAS AN ORIGINAL UNKNOWN SURGERY OCCURRED ON (B)(6), 2020. POST-OPERATIVELY ON AN UNKNOWN DATE, ADJACENT SEGMENT DISEASE (ASD) OCCURRED. A REVISION SURGERY OCCURRED TO EXTEND FIXATION AND REMOVE HARDWARE ON (B)(6), 2023. THE SFX CROSS-LINK WAS REMOVED. SET SCREW AND ROD WERE REMOVED. OF THE SCREWS IN L3-5, ONLY L3 AND L4 SCREWS WERE REMOVED. (BONE FUSION WAS COMPLETED) L5 SCREW WERE PRESERVED. S ADDITIONAL SCREW OF 7.0-45MM DIAMETER WAS INSERTED. L5-S TLIF WAS PERFORMED.(CAGE WAS OTHER COMPANY¿S PRODUCT.) SFX CROSS-LINK WAS PLACED, AND THE FINAL TIGHTENING WAS DONE. THIS REPORT IS FOR ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 50MM FOR (B)(4). (B)(4) AND (B)(4) ARE LINKED. ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED FOR THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 18596716 ↗
• MalfunctionJun 27, 2023Difficult to Advance; Compatibility Problem; Difficult to Advance; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, A REOPERATION VIA POSTERIOR FUSION (L2 AND L3) WAS PERFORMED. THE SURGEON TRIED TO INSERT THE SCREW (7.0×50) INTO L3, BUT THERE WAS TREMENDOUS STRONG RESISTANCE, AND THE SCREW COULD NOT BE INSERTED FURTHER. THE SURGEON JUDGED TO SHAVE A BURR HOLE AGAIN USING A COMPETITORS INSTRUMENT AND THE SCREW WAS SUCCESSFULLY INSERTED INTO L3. AT THE TIME OF INSERTING THE SCREW INTO L2, THE SCREW WAS NOT INSERTED SMOOTHLY EITHER AND IT WAS REMOVED ONCE. AND THEN, SOMEHOW THE SURGEON FELT UNCOMFORTABLE, SO THE SURGEON CHANGED TO ANOTHER SCREWDRIVER, REPLACED THE SCREW JUST TO BE SURE, AND INSERTED A NEW SCREW INTO L2. DURING THE REOPERATION, A NURSE NOTICED THAT THE STAR SHAPE AT THE TIP OF THE SCREWDRIVER WAS ROUNDED OFF AND DISCOVERED THAT THE TIP OF THE SCREWDRIVER WAS STUCK IN THE CORE OF THE SCREW INSERTED INTO L3. THE METAL STUCK IN THE CORE OF THE SCREW WAS TRIED TO BE REMOVED BUT FAILED. A ROD WAS SET, AND THE SCREW WAS TRIED AGAIN TO BE REMOVED BY TURNING THE SCREW HEAD, BUT THE SCREW WAS INSERTED SO TIGHTLY SO THAT THE SCREW HEAD IDLED. AFTER REPEATING TURNING THE SCREW HEAD, THE METAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17211057 ↗
• InjuryDec 30, 2022Adverse 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 THE PATIENT UNDERWENT A PLIF ON (B)(6) 2018. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. ON (B)(6) 2022, AN EXTENSION TO THE UPPER VERTEBRAL BODY REVISION PLIF WAS SCHEDULED TO BE PERFORMED BECAUSE THE PATIENT DEVELOPED AN ADJACENT INTERVERTEBRAL DISORDER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 50MM. THIS IS REPORT 2 OF 12 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 16078286 ↗
• InjuryDec 30, 2022Adverse 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 THE PATIENT UNDERWENT A PLIF ON (B)(6) 2018. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. ON (B)(6) 2022, AN EXTENSION TO THE UPPER VERTEBRAL BODY REVISION PLIF WAS SCHEDULED TO BE PERFORMED BECAUSE THE PATIENT DEVELOPED AN ADJACENT INTERVERTEBRAL DISORDER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 50MM. THIS IS REPORT 1 OF 12 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 16078277 ↗
• MalfunctionApr 14, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON USED CUSTOM AWLS TO ACCESS THE PEDICLE, AND THEN INSERTED THE 7.0X50MM CORTICAL FIX SCREW AT L5 ON THE RIGHT SIDE. AS THE SCREW WAS BEING INSERTED THE TULIP HEAD POPPED OFF DISENGAGING FROM THE BODY OF THE SCREW. THE SURGEON ATTEMPTED TO REMOVE THE BODY OF THE SCREW WITH A T20 DRIVER BUT STRIPPED THE T20 CANNULATED DRIVER. THE SURGEON ALSO STRIPPED THE T20 NON CANNULATED DRIVER AND FRACTURED THE TIP OF THE MINI OPEN DRIVER. THE BROKEN TIP OF THE MINI OPEN DRIVER WAS POSSIBLY INSIDE THE HEX OF THE SCREW. THE NEXT ATTEMPT TO REMOVE THE SHAFT OF THE SCREW WAS TO USE A SCREW REMOVAL REVERSE THREAD INSTRUMENT, WHICH FAILED TO REMOVE THE SCREW. THE SURGEON WAS ABLE TO SUCCESSFULLY REMOVE THE FRACTURED INSTRUMENT AND CONFIRMED WITH BOTH X-RAY AND MATCHING IT UP, THAT THE INSTRUMENT WAS REMOVED. THE SCREW REMAINED IN THE PATIENT WITH A RESCUE SCREW 5.0X50MM PLACED DIRECTLY BESIDE IT. TO INSERT THE RESCUE SCREW, THE SURGEON USED A JAM SHIDI, AND GUIDE WIRE WITH 4.35MM TAP. THE RESCUE SCREW HAD NO ISSUE, AND THE SURGEON WAS ABLE TO PASS THE ROD AND FINISH UP. THE TULIP WAS RECOVERED, THE SHAFT OF THE 7.0X50MM SCREW REMAINS IN THE PATIENT, THE

  Patient problems: Foreign Body In Patient

  MAUDE report 11666047 ↗
• MalfunctionJun 1, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING THE INSERTION OF THE FIRST VIPER 2 CORTICAL FIXED SCREW INTO THE PEDICLE, THE SURGEON FELT SOME RESISTANCE WITH AUDIBLE SOUND OF TIGHTNESS OF INSERTING THE SCREW. AFTER A FEW TURNS, SURGEON ASSUMED THAT THE SCREW WENT INTO THE VERTEBRAL BODY. UPON CHECKING WITH FLUOROSCOPE, THE SCREW ONLY STOPPED AT THE PEDICLE AND COULDN'T TURN ANYMORE. THE SURGEON THEN TRIED TO REMOVE THE VIPER 2 CLOSED EXTENSION AND FOUND OUT THE SCREW HEAD DETACHED FROM THE SCREW SHAFT AND THE SCREW SHAFT WAS STILL INSIDE THE PEDICLE. AFTER THE REMOVAL OF THE SCREW SHAFT, HE INSERTED VIPER 2 CORTICAL FIXED SCREW AND IT WENT IN PERFECTLY WITH NO ISSUE. HE INSERTED THE SAME SCREW SIZE AND LENGTH INTO OTHER PEDICLE AND THERE IS NO ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN HOUR SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10106272 ↗
• InjurySep 20, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON PERFORMED A REVISION POSTERIOR SPINAL FUSION WHICH INCLUDED REMOVAL OF THE PRIOR IMPLANTED SPINAL ELEMENTS - MERCURY CLASSIC HARDWARE. THERE CONSTRUCT HARDWARE THAT WAS BEING REMOVED WAS FROM L2-L4 ON THE LEFT SIDE AND L2-S1 ON THE RIGHT SIDE. THEY SUCCESSFULLY REMOVED ALL THE HARDWARE AND REPLACED THE PEDICLE SCREWS WITH VIPER CORTICAL FIX SCREWS. ALL THE SCREWS WERE PLACED SUCCESSFULLY. THE EVENT HAPPENED PRIOR TO PLACING THE RODS. THE SURGEON WANTED TO ADVANCE THE RIGHT SIDED PEDICLE SCREW INTO THE PEDICLE ABOUT A THREAD. ACCORDING TO THE SURGEON, HE ASKED FOR AN EXPEDIUM QUICK CONNECT POLY DRIVER AND ATTEMPTED TO ADVANCE THE SCREW WITHOUT ENGAGING THE SLEEVE TO THE POLY-HEAD. THE SCREW MADE A SCREECHING SOUND THEN THE TIP OF THE SCREW BROKE OFF. EARLIER IN THE CASE THE SURGEON REMOVED THE MERCURY 6.5X50MM PEDICLE SCREW AND IMPLANTED A 7X50 VIPER CORTICAL FIX SCREW AND HEARD THE SCREW MAKING SQUEALING NOISES AS HE IMPLANTED THE SCREW. AFTER THE POLY DRIVER BROKE, THE SURGEON SEATED A 30MM X5.5MM TI ROD INTO THE HEAD OF THAT SCREW AND PLACED A SET SCREW IN THE HEAD. THE SURGEON FINAL TIGHTENED THE SET SCREW. THEN HE TRIED TO BACK O

  Patient problems: Foreign Body In Patient

  MAUDE report 9100334 ↗
• MalfunctionJan 24, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT ON DECEMBER 18TH, DR. (B)(6) WAS PERFORMING A REVISION OF A PRIOR FUSION WITH BILATERAL PEDICLE SCREWS FROM L3-S1. WHILE USING THE T25 ATTACHMENT (ITEM: HD203T25) FROM THE SRB SET, HE TRIED TO LOOSEN ONE SET SCREW WHEN THE TIP OF THIS SHEERED OFF. THE PIECE WAS RETRIEVED AND ALL SCREWS WERE REMOVED SUCCESSFULLY. WHILE INSERTING A NEW 8X45MM SCREW (ITEM: 1867-31-845) INTO THE LEFT L3 PEDICLE, THE EXPEDIUM SCREW DRIVER (#2797-12-400) TIP BROKE OFF INSIDE THE SCREW. THE SCREW WAS REMOVED AND A NEW SCREW WAS SUCCESSFULLY PLACED. LATER IN THE CASE WHILE TRYING TO INSERT A NEW SCREW (#1867-31-750), THE SAME THING HAPPENED WHERE THE TIP OF THE EXPEDIUM DRIVER BROKE. AGAIN, AFTER THE SCREW HEAD/SCREW WAS REMOVED , A NEW REPLACEMENT WAS SUCCESSFULLY IMPLANTED. LATER IN THE CASE WHEN THE SURGEON WAS TRYING TO PLACE A 10X65MM SCREW (#1797-12-165), THE TIP OF ANOTHER SCREW DRIVER (ITEM# 2797-34-000) BROKE AS WELL. THE SCREW WAS PROPERLY PLACED SO NO ADJUSTMENT TO THE SCREW NEEDED TO ME MADE. I ASKED THE SURGEON IF THE BROKE TIP HAD STAYED IN THE SCREW ITSELF, AT WHICH POINT HE SAID HE BELIEVED IT DID. I STRONGLY RECOMMENDED THAT HE RETRIEVE THE BROKEN PIECE. I BELIEVE HE R

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8274218 ↗
• MalfunctionNov 16, 2018Disconnection; Material Split, Cut or Torn; Disconnection; Material Split, Cut or Torn

  IT WAS REPORTED THE POSTERIOR LUMBAR FUSION SURGERY WAS PERFORMED ON (B)(6) 2018 TO FIX L4 WITH UNDER -6MM TAPPING. DURING THE SURGERY, THE SURGEON FELT THE DIFFICULTY TO INSERT THE SCREW SINCE THE PATIENT HAS THE STRONG BONE QUALITY. THEN, IT WAS REPORTED THAT THE DRIVER TIP WAS BROKEN WITH THE CLICKING SOUND WHEN THE SURGEON INSERTED THE SCREW INTO THE PATIENT¿S BONE. THE SURGEON REMOVED ALL BROKEN FRAGMENT FROM THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED BY USING 7 X 45MM SCREW INTO THE SAME BONE HOLE. THERE WAS LESS THAN 30MIN. SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8080920 ↗
• MalfunctionDec 15, 2017Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  THE SURGEON WAS PERFORMING A REVISION REMOVING ANOTHER VENDOR¿S POSTERIOR PREDICABLE SCREWS (NUVASIVE ARMADA AND MEDTRONIC SOLEREA 5.5 L2-S1 SCREW/RODS). THE PATIENT PRESENTED WITH SAGITTAL IMBALANCE, CORONA IMBALANCE AND RESULTING PAIN FROM PSEUDOARTHROSIS (FROM THE OTHER VENDOR¿S HARDWARE FAILURE). THE SURGEON WAS PERFORMING A T10 TO THE ILIUM POSTERIOR LATERAL FUSION INCLUDING A L2 3 COLUMN OSTEOTOMY. USING EXPEDIUM 5.5 TITANIUM SPINE SYSTEM AND VIPER CORTICAL FIX SCREWS. AFTER SUCCESSFULLY REMOVING THE NUVASIVE AND MEDTRONIC SCREWS DR. MORRISON USED THE O-ARM IN CONJUNCTION WITH STEALTH NAVIGATION TO CANNULATE THE PEDICLES. HE PLACED ALL OF HIS SCREWS AND WAS HAPPY WITH THEIR POSITIONING WITH THE EXCEPTION OF L3 ON THE RIGHT (REPLACED THE GLOBUS 6.5 X 50 MM SCREW WITH A 7.0 X 50 MM CORTICAL FOX SCREW. HE DID NOT TAP). HE REQUESTED AND EXPEDIUM T20 SPRING LOADED SCREWDRIVER THE BACK OUT THE L3 SCREW . HE BEGAN TO BACK OUT THE SCREW WHEN HE HEARD AND FELT THE TIP ON THE SCREWDRIVER BREAK IN THE CORTICAL FIX PEDICLE SCREW. HE THEN PROCEEDED TO USE A METAL CUTTING BURR TO CUT THE TIPPING HEAD OFF OF THE SHANK. HE THEN USED A 6.0 MM SCREW EXTRACTOR BIT FROM THE DEPUY SPINE SRB REMOV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7122021 ↗
• MalfunctionAug 3, 2017Break; Break

  ON (B)(6) 2017, THE SURGERY FOR SPINAL CANAL STENOSIS WAS PERFORMED USING THE EXPEDIUM SYSTEM. DURING THE SURGERY, ALTHOUGH THE SURGEON TRIED TO PUT A ROD (PART#: UNK) INTO THE SCREW, A SET SCREW (PART#: UNK) COULD NOT BE SET BECAUSE THE SCREW-HEAD OF THE REPORTED PRODUCT (PART#:186731750 / LOT#:140823) GOT BROKEN. THE SURGEON DEALT WITH THIS EVENT BY ADJUSTING THE BENDING OF THE ROD AND REPLACING THE REPORTED PRODUCT WITH A NEW ONE. NO BROKEN PARTS WERE CONFIRMED TO BE LEFT IN THE BODY AND THE SURGERY WAS SUCCESSFULLY DONE WITH A 30-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6764281 ↗