VIPER PRIME 286750033Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034507606), received between Feb 19, 2020 and Mar 27, 2023 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 CARRIER. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618365 ↗
• 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 CARRIER. THIS IS REPORT 4 OF 8 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618363 ↗
• MalfunctionMay 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRIA 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) / 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 APRIL 14, 2022 REPORTED OVER THE PHONE ABOUT

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

  MAUDE report 14378046 ↗
• MalfunctionApr 27, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) 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 INSERTER CARRIER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222794 ↗
• MalfunctionNov 24, 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, WHILE PASSING THE VIPER PRIME 6X40 SCREW MOUNTED IN ITS RESPECTIVE SCREWDRIVER AND WITH THE STYLET, IT DID NOT EASILY ENTER THE PATIENT'S BONE AND THE SURGEON DECIDED TO REMOVE. IT WAS EVIDENT THAT THE STYLET WAS BENT AND JAMMED IN THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FEW MINUTES OF SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: MIS SINGLE INNER SETSCW (PART# 186715000, LOT# 299238, QUANTITY 4); MIS CANN POLY SCW 6X40MM,TI (PART# 186715640 , LOT# 149511, QUANTITY 3); MIS CANN POLY SCW 6X40MM,TI (PART# 186715640, LOT# TBVMF, QUANTITY 1); VIPER2 LORDOTIC ROD-45MM (PART# 186788045, LOT# TBXZY, QUANTITY 1); CONF INTRO NDLE, DIA, 11G 6" (PART# 283903611, LOT# 271833, QUANTITY 2); VIPER PRIME STYLET (PART# 286750200S, LOT# 585424431, QUANTITY 1); VIPER PRIME STYLET (PART# 286750200S, LOT# SI5326111 , QUANTITY 1). THIS REPORT IS FOR ONE (1) VIPER PRIME INSERTER CARRIER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868456 ↗
• 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 CARRIER. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625273 ↗
• MalfunctionMay 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THERE WAS A PROBLEM WITH THE SCREWDRIVER ANCHOR AND THE REST OF THE SCREWDRIVER PARTS. THE SURGERY WAS EXTREMELY COMPLICATED, AND THE STYLET WAS BENT SEVERAL TIMES SO IT HAD TO BE ASSEMBLED AND DISASSEMBLED IT REPEATEDLY. THE NUT THAT SECURES THE SCREWS WAS LOCKED AT THE MOMENT OF LOOSENING THE SCREW AND THE PIECE THAT MOVES THE STYLET FORWARD BEGAN TO MAKE NOISES THAN IT SHOULD NOT HAVE MADE. THE SURGERY WAS COMPLETED SUCCESSFULLY. WITHOUT ANY AFFECTATION TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN DEPTH ADJUSTOR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER PRIME INSERTER CARRIER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11786603 ↗
• MalfunctionNov 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  ONLY THE SHAFT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10843263 ↗
• MalfunctionOct 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON HAD TO ABANDON USING THE CAGE, AND INSERTION INSTRUMENTS BECAUSE OF THEIR INABILITY TO MAINTAIN A STRAIGHT LINE. THE THREAD THAT CONNECTED THE SILVER HANDLE TO THE TIGHTENING DEVICE FOR THE CAGE WAS WORN, AND WAS A WEAK POINT IN THE INSERTION DEVICE MECHANISM. THE RATCHETED OR TENSION ATTACHMENT FOR THE CAGE CAUSED A DANGEROUS MISALIGNMENT OF THE BANANA CAGE DURING INSERTION. ONCE THE CAGE HAD BEEN ATTACHED TO THE INSERTION DEVICE IN THE CORRECT FASHION THE SURGEON SHOULD HAVE BEEN ABLE TO INSERT IT IN A DIRECT LINE WITH THE INSTRUMENT. THE ATTACHMENT OF THE CAGE WAS NOT ABLE TO HOLD THE STRAIGHT ALIGNMENT, AND UPON INSERTION THE CAGE FLEXED, AND WENT INTO THE SPINAL CANAL. IT IS CRUCIAL ESPECIALLY FOR MIS THAT THE CAGE BE ABLE TO BE INSERTED IN THE EXACT LINE THAT THE SURGEON PLACED IT IN. ONCE IN THE CORRECT POSITION OF THE DISC SPACE, IT CAN RELEASE THE TENSION. THE HANDLE CAN MOVE MEDIALLY, AND CAN GET IN THE DESIRED POSITION. WEAR OF THE INSERTION DEVICE CREATED AN UNSAFE SITUATION FOR THE PATIENT. THERE WAS A SURGICAL DELAY OF SIXTY (60) MINUTES. ANOTHER CAGE AND

  Patient problems: Not Applicable

  MAUDE report 10717803 ↗
• MalfunctionSep 2, 2020Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, AS THE SURGEON WAS ADVANCING THE VIPER PRIME PEDICLE SCREW, THE STYLER ADVANCED WAS DIFFICULT TO ADVANCE AND ROTATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR PRODUCT. THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: VIPER PRIME PEDICLE SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER PRIME INSERTER CARRIER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10485466 ↗
• InjuryFeb 19, 2020Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCRUB NURSE HAD DIFFICULTY LOADING IMPLANT. SURGEON WAS ABOUT TO IMPLANT BUT NOTICED THE CAGE WAS NOT STRAIGHT. INTERFACE WITH INSERTER WAS NOT STRAIGHT AND IN ALIGNMENT WITH INSERTER. WE TRIED ANOTHER CONCORDE BULLET INSERTER, BUT THE CAGE WAS STILL NOT STRAIGHT. HAD TO OPEN ANOTHER IMPLANT WHICH LOADED CORRECTLY. THE 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 REPORTED THAT THE IMPLANT WAS FAULTY. IMPLANT WAS DECONTAMINATED. THE VIPER PRIME SCREWDRIVER WAS NOT ABLE TO RELEASE SCREW AND STYLET WAS BENT AND HAD TO BE CUT. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT 10 MINUTES, NO FRAGMENTS WERE GENERATED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9727624 ↗