VIPER 186727840Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034282770), received between Oct 16, 2017 and Sep 27, 2022 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON INSERTED AN 8X40 CORTICAL FIX SCREW AND AFTER HEARING A STRANGE NOISE, REMOVED THE SCREW. ONCE IT CAME OUT, THE TULIP HEAD WAS DISMEMBERED FROM THE STEM. IN THE SAME SURGERY, AND ON THE SAME LEVEL (L3), ANOTHER IDENTICAL SCREW (SAME SIZE AND SAME LOT) BROKE THE TIP OF THE INSERTION SCREWDRIVER WHILE BEING INSERTED. ACCORDING TO THE SURGEON, THE PATIENT'S BONE WAS PARTICULARLY HARD. THE SURGERY WAS COMPLETED SUCCESSFULLY BUT DELAYED 45 MINUTES AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 40MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493532 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS BEING LOGGED TO CAPTURE THE REVISION ASSOCIATED WITH (B)(4) WHICH RECEIVED AS ADDITIONAL INFORMATION. IT WAS REPORTED THAT, THE REVISION OF POSTERIOR LUMBAR SPINAL FUSION WAS PERFORMED. THE REASON FOR REVISION WAS ADJACENT SEGMENT DEGENERATION/ADJACENT LEVEL DISEASE. THE EXPLANTED PRODUCTS WERE EXPEDIUM PEDICLE SCREWS AND CFX SCREWS, BUT THE LOT NUMBERS ARE NOT AVAILABLE. THE IMPLANTS WERE DISCARDED AND NOT AVAILABLE FOR COLLECTION. THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 40MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12433470 ↗
• InjuryMay 17, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT 1ST SURGERY ON (B)(6) 2018, FUSION L5-S1 WITH EXPEDIUM AND T-PAL. ON (B)(6) 2018, REVISION SURGERY BECAUSE OF RADICULOPATHY AND SUSPICION ON INFECTION. IMPLANTS WHERE LOOSE, HAVE BEEN REMOVED AND REPLACED. POST OP PAIN FREE. TISSUE HAS BEEN EXAMINED IN BACTERIOLOGY, ONE SAMPLE WAS POSITIVE. PATIENT SHOWED UP IN (B)(6) WITH BACK PAIN, EXAMINATIONS HAVE SHOWN AGAIN PSEUDARTHROSIS AND LOOSENING OF THE IMPLANTS. ON (B)(6), AGAIN REVISION SURGERY, REMOVAL OF ALL IMPLANTS, WHICH HAVE BEEN SENT IN FOR BACTERIOLOGICAL EXAMINATION. SEVERAL TISSUE SAMPLES WILL ALSO BE EXAMINED BACTERIOLOGICALLY. T-PAL CAGE WILL BE REMOVED FROM ANTERIOR AFTER THESE RESULTS OF THE BACTERIOLOGICAL EXAMINATION ARE KNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8621158 ↗
• InjuryMar 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION FOR BROKEN RODS - DR (B)(6) PRIVATE (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2015 DR (B)(6) PRIVATE. THE 1ST REVISION (B)(6) 2016 CF 5098185/(B)(4). THE 2ND REVISION (B)(6) 2016 CF 5098188/(B)(4). THE 3RD REVISION (B)(6) 2016 CF 5098030/(B)(4). THE 4TH REVISION (B)(6) 2018 PATIENT RE-OPERATED ON TO REPLACE BILATERAL BROKEN RODS AND LOOSENING OF 3 SCREWS IN LOWER SECTION OF CONSTRUCT L4- PELVIS, BELOW INLINE CONNECTORS. ALL SET SCREWS,ROD CONNECTORS,THREE LARGER DIAMETER SCREWS AND TWO RODS REPLACED REPLACE BELOW CONNECTION POINT OF UPPER CONSTRUCT. PATIENT INITIALS BE

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7354931 ↗
• InjuryMar 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION FOR BROKEN RODS - DR (B)(6) PRIVATE (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2015 DR (B)(6) PRIVATE. ON 1ST REVISION (B)(6) 2016 CF 5098185/(B)(4). ON 2ND REVISION (B)(6) 2016 CF 5098188/(B)(4). ON 3 REVISION (B)(6) 2016 CF 5098030/(B)(4). ON 4TH REVISION (B)(6) 2018 PATIENT RE-OPERATED ON TO REPLACE BILATERAL BROKEN RODS AND LOOSENING OF 3 SCREWS IN LOWER SECTION OF CONSTRUCT L4- PELVIS, BELOW INLINE CONNECTORS. ALL SET SCREWS, ROD CONNECTORS,THREE LARGER DIAMETER SCREWS AND TWO RODS REPLACED REPLACE BELOW CONNECTION POINT OF UPPER CONSTRUCT. PATIENT INITIALS BE

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7354842 ↗
• InjuryMar 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION FOR BROKEN RODS - DR (B)(6) PRIVATE (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2015 DR (B)(6) PRIVATE. ON 1ST REVISION (B)(6) 2016 CF 5098185/(B)(4). ON 2ND REVISION (B)(6) 2016 CF 5098188/(B)(4). ON 3RD REVISION (B)(6) 2016 CF 5098030/(B)(4). ON 4TH REVISION (B)(6) 2018 PATIENT RE-OPERATED ON TO REPLACE BILATERAL BROKEN RODS AND LOOSENING OF 3 SCREWS IN LOWER SECTION OF CONSTRUCT L4- PELVIS, BELOW INLINE CONNECTORS. ALL SET SCREWS,ROD CONNECTORS,THREE LARGER DIAMETER SCREWS AND TWO RODS REPLACED REPLACE BELOW CONNECTION POINT OF UPPER CONSTRUCT. (B)(6)

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7354724 ↗
• MalfunctionOct 16, 2017Break; Break

  CFX 8.0 MM SCREW DISMANTLED WHILE IMPLANTING IN L5 RIGHT LEVEL OF PATIENT. THE CFX SCREW WAS ALMOST TOTALLY SCREWED DOWN INTO THE PEDICLE BONE WHEN THE BALL-JOINT RUPTURED LEAVING THE SCREW HEAD TOTALLY AWAY FROM THE THREAD. HEAD AND DEBRIS OF RUPTURED BALL-JOINT WHERE IMMEDIATELY REMOVED WITH NO DAMAGE TO THE PATIENT. THE CFX SCREW THREAD WAS QUITE EASY REMOVED WITH HELP OF EXP.VIPER RESCUE SCREW-DRIVER. ANOTHER CFX WAS IMMEDIATELY INSERTED WITH NO PROBLEM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6952497 ↗