VIPER PRIME 286750131NRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705034507781), received between Jul 24, 2020 and Oct 20, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PRODUCT WAS WORN DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337063 ↗
• MalfunctionJul 7, 2025Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  SOMETHING IN THE TWISTING MECHANISM IS FAULTY/BROKEN. WHEN USED IN SURGERY, IT JAMS/SKIPS WHEN INSERTING THE SCREW, MAKING IT DANGEROUS AND DIFFICULT TO TRUST THE DIRECTION OF THE SCREW WHEN IT JAMS/SKIPS LIKE THAT. DISTRIBUTOR'S COMPLAINT FORM ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414735 ↗
• MalfunctionSep 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW COULD NO LONGER BE RELEASED FROM THE VIPER PRIME SCREWDRIVER. THERE WAS NO SURGICAL DELAY AND NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) VIPER PRIME NAV SHAFT ASSY THIS IS REPORT 2 OF 2 FOR COMPLAINT(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182584 ↗
• MalfunctionJun 5, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON MAY 19, 2023, THE LOAN TECHNICIAN DISCOVERED DIRTY CANNULATED INSTRUMENTS WHILE CHECKING THE ITEMS IN FOR A PENDING CASE. THIS WAS CAUGHT BEFORE THE SET WAS USED FOR A SPINAL FUSION PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE VIPER PRIME NAV SHAFT ASSY. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060279 ↗
• MalfunctionJun 5, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON MAY 19, 2023, THE LOAN TECHNICIAN DISCOVERED DIRTY CANNULATED INSTRUMENTS WHILE CHECKING THE ITEMS IN FOR A PENDING CASE. THIS WAS CAUGHT BEFORE THE SET WAS USED FOR A SPINAL FUSION PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE VIPER PRIME NAV SHAFT ASSY. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060079 ↗
• MalfunctionMar 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 07-MARCH-2021, THE DRIVER TIP WAS UNABLE TO SECURE TO THE HANDLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER PRIME NAV SHAFT ASSY. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618362 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE DRIVER TIP WAS UNABLE TO SECURE TO THE HANDLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) VIPER PRIME NAV SHAFT ASSY THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594853 ↗
• MalfunctionOct 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, IMPRECISION WAS ENCOUNTERED WHILE NAVIGATING SCREWS DURING A T5-L3 FIXATION PROCEDURE USING VIPER PRIME SCREWS (MOUNTED WITH A NON-SYNTHES PRODUCT). INTRA-OPERATIVE NAVIGATION SYSTEM AND 3D IMAGING WERE NON-SYNTHES PRODUCTS. THE FIRST NAVIGATION PHASE OCCURRED IN THE FOLLOWING ORDER: T5-R, T6-R, T7-R, T8-R, T9-R, T5-L, T6-L, T7-L, T8-L, T9-L, T10-L). NO APPARENT NAVIGATION ABNORMALITIES NOR INACCURACIES WERE COUNTERED DURING THIS NAVIGATION PHASE. NO INSTRUMENT RECALIBRATION NOR ADJUSTMENTS OF ANY SORT ON EITHER THE SCREWDRIVER OR THE PATIENT¿S REFERENCE HAD BEEN PERFORMED DURING THIS NAVIGATION PHASE. THE SECOND 3D NAVIGATION WAS ACQUIRED FOR CONTROL PURPOSES. THE POSITIONS OF THE FIRST 5 SCREWS PLACED ON THE UPPER RIGHT SIDE OF THE PATIENT (T5 ¿ T9 RIGHT) WERE FOUND TO BE ALL MEDIALLY SHIFTED. ALL OTHER SCREWS (T5 ¿ T9 LEFT) WERE FOUND TO BE CORRECTLY PLACED. THREE OUT OF THE 5 MISPLACED SCREWS HAD TO BE REMOVED / REPLACED (T5 R, T8 R AND T9 R). THIRD 3D NAVIGATION ACQUISITION WAS DONE FOR CONTROL PURPOSES. ALL REPLACED SCREWS (T5 R, T8 R AND T9 R) SHOWED TO BE PROPERLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15676150 ↗
• MalfunctionOct 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, IMPRECISION WAS ENCOUNTERED WHILE NAVIGATING SCREWS DURING A T5-L3 FIXATION PROCEDURE USING VIPER PRIME SCREWS (MOUNTED WITH A NON-SYNTHES PRODUCT). INTRA-OPERATIVE NAVIGATION SYSTEM AND 3D IMAGING WERE NON-SYNTHES PRODUCTS. THE FIRST NAVIGATION PHASE OCCURRED IN THE FOLLOWING ORDER: T5-R, T6-R, T7-R, T8-R, T9-R, T5-L, T6-L, T7-L, T8-L, T9-L, T10-L). NO APPARENT NAVIGATION ABNORMALITIES NOR INACCURACIES WERE COUNTERED DURING THIS NAVIGATION PHASE. NO INSTRUMENT RECALIBRATION NOR ADJUSTMENTS OF ANY SORT ON EITHER THE SCREWDRIVER OR THE PATIENT¿S REFERENCE HAD BEEN PERFORMED DURING THIS NAVIGATION PHASE. THE SECOND 3D NAVIGATION WAS ACQUIRED FOR CONTROL PURPOSES. THE POSITIONS OF THE FIRST 5 SCREWS PLACED ON THE UPPER RIGHT SIDE OF THE PATIENT (T5 ¿ T9 RIGHT) WERE FOUND TO BE ALL MEDIALLY SHIFTED. ALL OTHER SCREWS (T5 ¿ T9 LEFT) WERE FOUND TO BE CORRECTLY PLACED. THREE OUT OF THE 5 MISPLACED SCREWS HAD TO BE REMOVED / REPLACED (T5 R, T8 R AND T9 R). THIRD 3D NAVIGATION ACQUISITION WAS DONE FOR CONTROL PURPOSES. ALL REPLACED SCREWS (T5 R, T8 R AND T9 R) SHOWED TO BE PROPERLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15676099 ↗
• MalfunctionJun 13, 2022Break; Break

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, ONE OF THE PINS IN THE SURETRAK OF THE MEDTRONIC SYSTEM WAS BROKEN, LEADING TO INACCURATE NAVIGATION AND POOR PLACEMENT OF THE SCREW (TOO MEDIAL). THE SURGEON NEEDED TO REMOVE AND REPOSITION THE SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 20 MINUTE DELAY, AND NO PATIENT CONSEQUENCES OCCURRED. THIS REPORT IS FOR A NAVIGATION ENABLED INSTRUMENTS VIPER PRIME DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14680533 ↗
• MalfunctionMay 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A TEST PHASE WITH THE PERCUTANEOUS STABILIZATION SYSTEM "VIPER PRIME" IN COMBINATION WITH THE NAVIGATION SYSTEM FROM (B)(4) IN THE CONTEXT OF A PATIENT-SPECIFIC PATIENT INDICATION WAS OCCURRING AT THE LKH FELDKRICH / DEPARTMENT OF NEUROSURGERY. VARIOUS ORTHOKITS OF THE NAVIGABLE VIPER PRIME SYSTEM (INSTRUMENTS AND IMPLANTS) WERE STATIONED ON SITE. INSTRUCTION OF THE INSTRUMENTS WAS CONDUCTED ON SITE. DUE TO THE COMPLEXITY OF THE NAVIGATED VIPER PRIME SETTINGS, IT WAS ALSO VERBALLY AGREED WITH THE USERS THAT ANY OPERATIONS WITH THIS NAVIGABLE VIPER PRIME SET OF INSTRUMENTS MAY ONLY BE CARRIED OUT BY A SURGICAL ASSISTANT OR BY A REPRESENTATIVE. UP TO (B)(6) 2021, ABOUT 2-3 ACCOMPANIED SURGERIES OF THIS TYPE WERE SUCCESSFULLY CARRIED OUT BY DR (B)(6) AND/OR PRIMARY (B)(6). A SURGERY WAS PLANNED FOR (B)(6) 2021. NO OBJECTION TO CARRYING OUT SUCH SURGERIES EXCLUSIVELY WITH A SURGICAL ACCOMPANIMENT FROM A SYNTHES REPRESENTATIVE WAS JUSTIFIED IN SUCH A WAY THAT THE USERS ARE SUFFICIENTLY FAMILIAR WITH THIS SYSTEM AND THAT ALL IMPLANTS ARE COMPLETE. DR. (B)(6) ON (B)(6) 2022 REPORTED OVER THE PHONE ABOUT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14380010 ↗
• MalfunctionNov 29, 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 AN UNKNOWN PROCEDURE, THE VIPER PRIME SCREWDRIVER TIP WAS DISCOVERED AS WORN OUT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER PRIME NAV SHAFT ASSY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883790 ↗
• MalfunctionOct 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE VIPER PRIME SCREW WAS UNABLE TO DETACH FROM THE VIPER PRIME SCREWDRIVER. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND SCREWDRIVER FROM THE SET. THIS REPORT IS FOR ONE (1) VIPER PRIME NAV SHAFT ASSY. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632083 ↗
• MalfunctionJul 28, 2021Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A NUVASIVE LATERAL PROCEDURE, THE SURGEON REPORTED THAT THE NAVIGATED VIPER PRIME DRIVER DID NOT PROPERLY FUNCTION. THE ARTICULATING PART OF THE DRIVER WAS DIFFICULT TO ROTATE. THE NAVIGATED VIPER PRIME DRIVER COULD NOT BE DISASSEMBLED. THE PROCEDURE WAS DELAYED BY ONE HOUR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) VIPER PRIME NAV SHAFT ASSY THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239628 ↗
• MalfunctionJul 28, 2021Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A NUVASIVE LATERAL PROCEDURE, THE SURGEON REPORTED THAT THE NAVIGATED VIPER PRIME DRIVER DID NOT PROPERLY FUNCTION. THE ARTICULATING PART OF THE DRIVER WAS DIFFICULT TO ROTATE. THE NAVIGATED VIPER PRIME DRIVER COULD NOT BE DISASSEMBLED. THE PROCEDURE WAS DELAYED BY ONE HOUR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) VIPER PRIME NAV SHAFT ASSY. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239626 ↗
• MalfunctionMay 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING SPINAL FUSION SURGERY THE NAVLOCK VIPER PRIME DRIVER DOES NOT HAVE A SOLID CONNECTION WITH THE SCREW. THE SCREW "WOBBLES" ON THE DRIVER TIP. ALSO, DIFFICULTY INSERTING INTO THE NAVLOCK ARRAYS. THEY HAD TO SWAP DRIVERS. THERE WAS NO FRAGMENT GENERATED. THERE WAS A SURGICAL DELAY OF 2.5 HOURS. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME NAV SHAFT ASSY. THIS REPORT IS 7 OF 7 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780580 ↗
• MalfunctionMay 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING SPINAL FUSION SURGERY THE NAVLOCK VIPER PRIME DRIVER DOES NOT HAVE A SOLID CONNECTION WITH THE SCREW. THE SCREW "WOBBLES" ON THE DRIVER TIP. ALSO, DIFFICULTY INSERTING INTO THE NAVLOCK ARRAYS. THEY HAD TO SWAP DRIVERS. THERE WAS NO FRAGMENT GENERATED. THERE WAS A SURGICAL DELAY OF 2.5 HOURS. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME NAV SHAFT ASSY THIS REPORT IS 6 OF 7 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11779725 ↗
• MalfunctionMay 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING SPINAL FUSION SURGERY THE NAVLOCK VIPER PRIME DRIVER DOES NOT HAVE A SOLID CONNECTION WITH THE SCREW. THE SCREW "WOBBLES" ON THE DRIVER TIP. ALSO, DIFFICULTY INSERTING INTO THE NAVLOCK ARRAYS. THEY HAD TO SWAP DRIVERS. THERE WAS NO FRAGMENT GENERATED. THERE WAS A SURGICAL DELAY OF 2.5 HOURS. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME NAV SHAFT ASSY. THIS REPORT IS 1 OF 7 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778606 ↗
• MalfunctionDec 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020, THAT THE PATIENT UNDERWENT FOR AN UNKNOWN PROCEDURE. IT WAS DISCOVERED THAT THE TIP OF THE INSERTER SHAFT WAS WOBBLY. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT CONDITION WAS REPORTED STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) VIPER PRIME NAV SHAFT ASSY THIS REPORT IS 1 OF 1 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11067672 ↗
• MalfunctionOct 26, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  CONCOMITANT DEVICES: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 3). UNKNOWN HAMMER/MALLET(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10734694 ↗
• MalfunctionJul 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6). 2020, DURING THE L4-5 MIS TLIF SURGERY, THE VIPER PRIME SCREW GOT STUCK TO THE GREEN KNOB ON THE VIPER PRIME SCREWDRIVER. IT COULD NOT BE REMOVED. THE SURGEON'S TECHNIQUE DOES NOT USE THE STYLET. HE USES BLUNT K-WIRE. SECOND SCREWDRIVER IN THE SET WAS USED. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN K-WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) VIPER PRIME NAV SHAFT ASSY. THIS IS REPORT 01 OF 02 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10323036 ↗