VIPER PRIME 286750032Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705034507590), received between Dec 20, 2019 and Dec 23, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE INSERTING THE VIPER PRIME SCREW, THE VIPER PRIME INSERTION HANDLE BROKE IN HALF AFTER THE SECOND HAMMER STRIKE. THE INSTRUMENT WAS STILL ABLE TO BE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO DELAY OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877661 ↗
• MalfunctionFeb 9, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED DURING A SURGERY ON (B)(6) 2024 THE VIPER PRIME INSERTER HANDLE BROKE WHEN INSERTING THE SCREW. SURGERY WAS DELAYED 10 MINUTES. THE SURGEON REPLACED THE INSTRUMENT AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE VIPER PRIME INSERTER HANDLE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677500 ↗
• MalfunctionSep 19, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775604 ↗
• 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 INSERTER HANDLE. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618374 ↗
• MalfunctionMar 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 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 INSERTER HANDLE. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618372 ↗
• 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 BRAINLAB IN THE CONTEXT OF A PATIENT-SPECIFIC PATIENT INDICATION WAS OCCURRING AT THE (B)(6) 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 BAUER. 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 A PATIENT SPECIFIC CA

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

  MAUDE report 14377720 ↗
• MalfunctionApr 27, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) FOR TREATING SPINAL CANAL STENOSIS THE INSERTER HANDLE WAS ATTACHED TO THE INSERTER CARRIER AND A RED POWDER-LIKE FOREIGN SUBSTANCE CAME OUT. THEY REATTACHED THE DEVICES A FEW TIMES, BUT THE FOREIGN SUBSTANCE CAME OUT OVER AND OVER. THE DEVICES WERE NOT USED IN THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THIS REPORT IS FOR ONE (1) VIPER PRIME SET SCRW INSERT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222552 ↗
• MalfunctionOct 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021. WHEN PREPARING FOR A PRODUCT DEMO USING THE VIPER PRIME DRIVER, WHEN HE TRIED TO TAKE IT APART THE SET SCREW IN THE INSERTER SHAFT STRIPPED AND CANNOT TAKE APART THE DRIVER. THERE WAS NO PATIENT INVOLVEMENT. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) VIPER PRIME INSERTER HANDLE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625253 ↗
• MalfunctionDec 1, 2020Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN THE STERILIZATION DEPARTMENT THAT FOUR (4) HANDLES HAVE TWO (2) SMALL SCREWS THAT CANNOT BE CLEANED PROPERLY AFTER SEVERAL USES. THE SURFACE OF THE SCREWS GRADUALLY BECOMES LESS SMOOTH AND "DIRT" COLLECTS ON THEM. THIS REPORT IS FOR ONE (1) VIPER PRIME INSERTER HANDLE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10929765 ↗
• MalfunctionDec 1, 2020Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN THE STERILIZATION DEPARTMENT THAT FOUR (4) HANDLES HAVE TWO (2) SMALL SCREWS THAT CANNOT BE CLEANED PROPERLY AFTER SEVERAL USES. THE SURFACE OF THE SCREWS GRADUALLY BECOMES LESS SMOOTH AND "DIRT" COLLECTS ON THEM. THIS REPORT IS FOR ONE (1) VIPER PRIME INSERTER HANDLE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10929737 ↗
• MalfunctionDec 1, 2020Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN THE STERILIZATION DEPARTMENT THAT FOUR (4) HANDLES HAVE TWO (2) SMALL SCREWS THAT CANNOT BE CLEANED PROPERLY AFTER SEVERAL USES. THE SURFACE OF THE SCREWS GRADUALLY BECOMES LESS SMOOTH AND "DIRT" COLLECTS ON THEM. THIS REPORT IS FOR ONE (1) VIPER PRIME INSERTER HANDLE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10929727 ↗
• MalfunctionDec 1, 2020Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN THE STERILIZATION DEPARTMENT THAT FOUR (4) HANDLES HAVE TWO (2) SMALL SCREWS THAT CANNOT BE CLEANED PROPERLY AFTER SEVERAL USES. THE SURFACE OF THE SCREWS GRADUALLY BECOMES LESS SMOOTH AND "DIRT" COLLECTS ON THEM. THIS REPORT IS FOR ONE (1) VIPER PRIME INSERTER HANDLE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10929726 ↗
• MalfunctionOct 26, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  THIS IS REPORT 1 OF 4 FOR (B)(4).

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

  MAUDE report 10734677 ↗
• MalfunctionSep 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  UPDATED CONCOMITANT DEVICES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10534835 ↗
• MalfunctionFeb 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: VIPER PRIME STYLET (PART # 286750200S, LOT # UNKNOWN, QUANTITY 1); THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9742182 ↗
• MalfunctionFeb 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: VIPER PRIME STYLET (PART # 286750200S, LOT # UNKNOWN, QUANTITY 1); THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9742175 ↗
• InjuryDec 20, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR (TLIF) PROCEDURE ON (B)(6) 2019, THE SCRUB NURSE HAD HAD DIFFICULTY LOADING THE IMPLANT. THE SURGEON WAS ABOUT TO IMPLANT BUT NOTICED THE CAGE WAS NOT STRAIGHT; THE INTERFACE WITH INSERTER WAS NOT STRAIGHT AND IN ALIGNMENT WITH INSERTER. ANOTHER CONCORDE BULLET INSERTER WAS TRIED, BUT THE CAGE WAS STILL NOT STRAIGHT. ANOTHER IMPLANT HAD TO BE OPENED, WHICH LOADED CORRECTLY. SURGEON WAS GETTING S1 NERVE ROOT IRRITATION WITH NEUROMONITORING SO IMPLANTED AND REMOVED SECOND IMPLANT. HAD TO GET CT SCAN AND NAVIGATE REMAINING SCREWS. IT WAS ALSO REPORTED THAT A VIPER PRIME SCREWDRIVER WAS NOT ABLE TO RELEASE SCREW AND STYLET WAS BENT AND HAD TO BE CUT. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PATIENT IS RECOVERING WELL. CONCOMITANT DEVICES: SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A VIPER PRIME INSERTER HANDLE. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9504371 ↗