VIPER 186731640Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034351827), received between Jul 14, 2017 and Nov 2, 2023 — classified as 9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 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 THERE WAS POSTERIOR LUMBAR INTERBODY FUSION (L4/5) PERFORMED ON (B)(6) 2014. AFTER THE SURGERY, ASD OCCURRED. THE REOPERATION TO EXTEND FIXATION WILL BE PERFORMED ON OCTOBER 23, 2023. THE EXP SINGLE INNER SETSCREW, MMSI ROD AND SFX 5.5 TRANSV CONN 49-66 MM IN QUESTION WILL BE REPLACED. 5.5 CANNULATED CORTICAL FIX SCREW 6X40MM AND CONC BULLET PARALLEL IN QUESTION WILL BE PRESERVED. THE EXTENSION SURGERY (L/S2) WILL BE PERFORMED WITH ALAR ILIAC, OLIF WILL BE PERFORMED FOR L2/3 AND L3/. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 6 X 40MM. THIS IS REPORT 9 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18055601 ↗
• InjuryNov 2, 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 THERE WAS POSTERIOR LUMBAR INTERBODY FUSION (L4/5) PERFORMED ON (B)(6) 2014. AFTER THE SURGERY, ASD OCCURRED. THE REOPERATION TO EXTEND FIXATION WILL BE PERFORMED ON (B)(6) 2023. THE EXP SINGLE INNER SETSCREW, MMSI ROD AND SFX 5.5 TRANSV CONN 49-66 MM IN QUESTION WILL BE REPLACED. 5.5 CANNULATED CORTICAL FIX SCREW 6X40MM AND CONC BULLET PARALLEL IN QUESTION WILL BE PRESERVED. THE EXTENSION SURGERY (L/S2) WILL BE PERFORMED WITH ALAR ILIAC, OLIF WILL BE PERFORMED FOR L2/3 AND L3/. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 6 X 40MM. THIS IS REPORT 10 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: Osteolysis

  MAUDE report 18055591 ↗
• InjurySep 13, 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 PSF (POSTERIOR SPINAL FUSION) AT T9-L1 WAS PERFORMED ON (B)(6) 2014. AFTER SURGERY, A PRESSURE ULCER WAS OBSERVED AT THE UPPER END OF T9. IC WAS HELD BETWEEN THE SURGEON AND THE PATIENT TO CONFIRM WHETHER TO REMOVE ONLY THE ROD AT THE AFFECTED SITE, OR TO REMOVE ALL THE IMPLANTS. IT WAS DECIDED TO REMOVE ALL IMPLANTS. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023. BONE UNION IS COMPLETE. ALL IMPLANTS WERE REMOVED WITHOUT ANY PROBLEMS, AND THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 6 X 40MM. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17735836 ↗
• InjurySep 13, 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 PSF (POSTERIOR SPINAL FUSION) AT T9-L1 WAS PERFORMED ON (B)(6) 2014. AFTER SURGERY, A PRESSURE ULCER WAS OBSERVED AT THE UPPER END OF T9. IC WAS HELD BETWEEN THE SURGEON AND THE PATIENT TO CONFIRM WHETHER TO REMOVE ONLY THE ROD AT THE AFFECTED SITE, OR TO REMOVE ALL THE IMPLANTS. IT WAS DECIDED TO REMOVE ALL IMPLANTS. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023. BONE UNION IS COMPLETE. ALL IMPLANTS WERE REMOVED WITHOUT ANY PROBLEMS, AND THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 6 X 40MM. THIS IS REPORT 5 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17735749 ↗
• InjuryJan 17, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (L4 TO S) FOR THE LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH MORE THAN 30 MINUTES DELAY. AFTER THE SURGERY, PARALYSIS REMAINED. POSTOPERATIVE CT SHOWED THAT THE LEFT SCREW OF L4 BACKED OUT SLIGHTLY INWARD. THE CAUSE OF RESIDUAL PARALYSIS IS UNKNOWN WHETHER IT WAS DUE TO INSUFFICIENT DECOMPRESSION OR SCREW BACK-OUT. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. ACCORDING TO THE SURGEON, THIS EVENT WAS NOT THE PRODUCT PROBLEM, BUT A RESULT OF THE INSERTION POINT BEING INSIDE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 6X40MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Paralysis

  MAUDE report 16184768 ↗
• MalfunctionJul 30, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE FOR TLIF IN THE LUMBAR SPINE (5/S1) TREATING LUMBAR SPONDYLOLISTHESIS THE SCREW WOULD NOT TIGHTEN AT L5 LEFT. THE SCREW THREADS WERE STRIPPED. THERE WERE NO FRAGMENT LEFT IN THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT LESS THAN 30-MINUTE SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 6 X 40MM. THIS IS REPORT 1 OF 2 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253784 ↗
• InjurySep 14, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A SPINAL FUSION PROCEDURE IN C2-TH4 TO TREAT THE DROPPED HEAD, THE SURGEON INSTRUCTED THE NURSE TO PREPARE SCREWS, BUT SHE MISTAKENLY PREPARED LONGER SCREWS. THOSE SCREWS WERE INSERTED AND LATER REPLACED WITH CORRECT SCREWS. THE PROCEDURE WAS DELAYED FOR THIRTY (30) MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 6X40MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 10532299 ↗
• InjurySep 14, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A SPINAL FUSION PROCEDURE IN C2-TH4 TO TREAT THE DROPPED HEAD, THE SURGEON INSTRUCTED THE NURSE TO PREPARE SCREWS, BUT SHE MISTAKENLY PREPARED LONGER SCREWS. THOSE SCREWS WERE INSERTED AND LATER REPLACED WITH CORRECT SCREWS. THE PROCEDURE WAS DELAYED FOR THIRTY (30) MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 6X40MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 10532288 ↗
• InjuryAug 8, 2018Break; Break

  ON (B)(6) 2015, THE PLIF SURGERY FOR SPINAL CANAL STENOSIS WAS PERFORMED BY USING THE EXPEDIUM SPINE SYSTEM. THE FIXED SITE WAS L5 AT WHICH SCREWING WAS DONE BY THE CORTICAL BONE TRAJECTORY (CBT) TECHNIQUE. AFTER THE SURGERY, ON (B)(6) 2018, THE RE-OPERATION WAS PERFORMED BECAUSE IT WAS FOUND THAT TWO SCREWS DISTALLY LOCATED HAD BEEN BROKEN OUT OF SIX SCREWS ((B)(4)). THE RE-OPERATION WAS PERFORMED TO EXTRACT ALL THE SIX SCREWS AND IMPLANT NEW SCREWS BY THE TRADITIONAL PEDICLE SCREW (PS) TECHNIQUE. DURING THE RE-OPERATION, FIVE SCREWS WERE SUCCESSFULLY EXTRACTED, BUT ONE OF THE TWO BROKEN SCREWS COULD NOT BE EXTRACTED BECAUSE IT HAD BEEN BROKEN AT A DEEP SITE. THE RE-OPERATION WAS COMPLETED WITH THE ONE BROKEN SCREW LEFT IN THE PATIENT¿S BONE THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON COMMENTED THAT THE HEAD ANGLE MIGHT HAVE NOT REACHED THE REQUIRED ANGULATION.

  Patient problems: Spinal Column Injury

  MAUDE report 7761877 ↗
• InjuryAug 8, 2018Break; Break

  ON (B)(6) 2015, THE PLIF SURGERY FOR SPINAL CANAL STENOSIS WAS PERFORMED BY USING THE EXPEDIUM SPINE SYSTEM. THE FIXED SITE WAS L5 AT WHICH SCREWING WAS DONE BY THE CORTICAL BONE TRAJECTORY (CBT) TECHNIQUE. AFTER THE SURGERY, ON (B)(6) 2018, THE RE-OPERATION WAS PERFORMED BECAUSE IT WAS FOUND THAT TWO SCREWS DISTALLY LOCATED HAD BEEN BROKEN OUT OF SIX SCREWS (186731640). THE RE-OPERATION WAS PERFORMED TO EXTRACT ALL THE SIX SCREWS AND IMPLANT NEW SCREWS BY THE TRADITIONAL PEDICLE SCREW (PS) TECHNIQUE. DURING THE RE-OPERATION, FIVE SCREWS WERE SUCCESSFULLY EXTRACTED, BUT ONE OF THE TWO BROKEN SCREWS COULD NOT BE EXTRACTED BECAUSE IT HAD BEEN BROKEN AT A DEEP SITE. THE RE-OPERATION WAS COMPLETED WITH THE ONE BROKEN SCREW LEFT IN THE PATIENT¿S BONE THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON COMMENTED THAT THE HEAD ANGLE MIGHT HAVE NOT REACHED THE REQUIRED ANGULATION.

  Patient problems: Spinal Column Injury

  MAUDE report 7761712 ↗
• MalfunctionDec 21, 2017Torn Material; Torn Material

  SURGEON WAS FINALLY TIGHTENING THE SET SCREWS IN A L2-S1 PERCUTANEOUS LUMBAR FUSION WHEN THE S1 SET SCREW ON THE LEFT SIDE OF THE PATIENT WOULD NOT TORQUE OUT. UPON INSPECTION, THE SET SCREW WAS NOT FLUSH WITH THE TOP OF THE TULIP HEAD. ALL SET SCREWS AND THE ROD WERE REMOVED. THE LEFT S1 SCREW WAS THEN REMOVED AND A NEW SCREW WAS INSERTED. ROD AND SET SCREWS WERE THEN REINSERTED AND ALL SET SCREWS WERE FINALLY TIGHTENED TO THE APPROPRIATE TORQUE. PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION:INCREASED ANESTHESIA TIME. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7139683 ↗
• MalfunctionJul 14, 2017Torn Material; Torn Material

  SURGEON FACING DIFFICULTIES USING THE VIPER 3D SYSTEM PERSUADER TO PERSUADE DOWN THE ROD DOWN WHICH CONSISTS OF FEW PARTS AS BELOW: 286735730 - DEROTATION REDUCTION THREADED POST, 286735725 - DEROTATION REDUCTION SHAFT, 286735750 - REDUCTION CAP, 286735735 - DEROTATION REDUCTION HANDLE WHEN SURGEON TRIED TO INSERT AND TIGHTEN THE INNIE NUT, HE WASN'T ABLE TO TURN THE DEROTATION REDUCTION HANDLE AS IT WAS TIGHT. THEN HE TOOK OUT THE NUT AND FOUND IT HAS CROSS-THREADED AS WELL AS THE SCREW HEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6714280 ↗