VIPER PRIME 286750041Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705034507644), received between Nov 22, 2019 and Dec 1, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT THE STYLET DEPTH ADJUSTOR BROKE WHILE TAKING IT OUT OF THE SCREWDRIVER. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681218 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 THE INSTRUMENTS BROKE INTRAOPERATIVELY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) PRIME STYLET DEPTH ADJUSTOR THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163095 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 THE INSTRUMENTS BROKE INTRAOPERATIVELY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) PRIME STYLET DEPTH ADJUSTOR. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162315 ↗
• MalfunctionSep 14, 2023Break; Break

  IT WAS REPORTED THAT THE PRODUCT CAME APART DURING THE DISASSEMBLY OF THE DEVICE AFTER THE CASE-DEPTH ADJUSTER CAME APART INTO THREE PIECES AND IS NO LONGER USABLE. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS NO MEDICAL INTERVENTION. THIS REPORT IS FOR ONE (1) PRIME STYLET DEPTH ADJUSTOR THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744049 ↗
• MalfunctionJan 26, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PRIME STYLET DEPTH ADJUSTER HAS DISMANTLED AT THE MOVING WINDOW END INTO THREE PIECES. THERE WAS NO DELAY TO SURGERY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME STYLET DEPTH ADJUSTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247868 ↗
• MalfunctionApr 18, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A SPINAL FUSION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE HANDLE FROM THE DRIVER WAS DAMAGED THAT THE HANDLE WAS NOT ABLE TO BE PLACED ON THE SCREWDRIVER. IT WAS FURTHER REPORTED THAT THE STYLET DEPTH ADJUSTER END RING WAS DAMAGED AND COMPLETELY CAME OFF WHILE TRYING TO REMOVE THE BENT STYLET FROM THE SCREWDRIVER. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) PRIME STYLET DEPTH ADJUSTOR DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137327 ↗
• MalfunctionNov 24, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  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) PRIME STYLET DEPTH ADJUSTOR. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868480 ↗
• MalfunctionJul 15, 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 THE NURSE WANTED TO REMOVE THE PRIME STYLET DEPTH ADJUSTOR FROM THE SCREWDRIVER TO ADAPT THE STYLET DEPTH. WHILE REMOVING IT, IT GOT STUCK IN THE T-HANDLE. IT WAS NOT POSSIBLE TO REMOVE EITHER OF THE ARTICLES FROM THE SCREWDRIVER. THE DEPTH ADJUSTER WAS PUSHED BACK WITH A HAMMER AND THE T-HANDLE WAS REMOVED. THE HEIGHT WAS THE ABLE TO BE ADJUSTED. THERE WAS A TWO (2) MINUTE SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) PRIME STYLET DEPTH ADJUSTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174491 ↗
• MalfunctionJun 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DURING ASSEMBLY OF THE VIPER PRIME INSERTER, THEY WERE UNABLE TO INTRODUCE THE STYLET GAUGE INTO THE TOP OF THE INSTRUMENT DUE TO REPETITIVE IMPACT DAMAGE TO THE TOP OF BOTH T-HANDLES. THE STYLET GAUGE THEN NEEDED TO BE INTRODUCED WITHOUT THE HANDLE IN-SITU, WITH THE HANDLE THEN APPLIED RETROSPECTIVELY. THIS WAS DONE FOR BOTH INSERTERS. NO IMPACT OR DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032239 ↗
• MalfunctionJun 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DURING ASSEMBLY OF THE VIPER PRIME INSERTER, THEY WERE UNABLE TO INTRODUCE THE STYLET GAUGE INTO THE TOP OF THE INSTRUMENT DUE TO REPETITIVE IMPACT DAMAGE TO THE TOP OF BOTH T-HANDLES. THE STYLET GAUGE THEN NEEDED TO BE INTRODUCED WITHOUT THE HANDLE IN-SITU, WITH THE HANDLE THEN APPLIED RETROSPECTIVELY. THIS WAS DONE FOR BOTH INSERTERS. NO IMPACT OR DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032206 ↗
• 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) PRIME STYLET DEPTH ADJUSTOR. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11786302 ↗
• MalfunctionMar 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SPINE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021 DURING THE PROCEDURE, (1) UNKNOWN SCREWDRIVER, (1) VIPER PRIME HANDLE, AND (1) PRIME STYLET DEPTH ADJUSTOR WERE UNABLE TO BE DISASSEMBLED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER SCREWDRIVER IN THE SET. THIS REPORT IS FOR (1) PRIME STYLET DEPTH ADJUSTOR. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11489587 ↗
• MalfunctionSep 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  10/16/2020: THIS COMPLAINT INVOLVES ELEVEN (11) DEVICE, THIS (B)(4) CAPTURES THE 10 OUT OF 11 DEVICES REPORTED/RECEIVED WHILE (B)(4) CAPTURES THE OTHER 1 OUT OF 11 DEVICES REPORTED/RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10534860 ↗
• MalfunctionJul 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR POSTERIOR LUMBAR INTERBODY FUSION IN L4-S1 TREATING SPINAL CANAL STENOSIS ON (B)(6) 2020. THE FLANGE OF A STYLET DID NOT FIT IN ALL THE SLOTS OF THE DEPTH ADJUSTER. THE SURGEON WAS NOT ABLE TO FIX SCREWS ON BOTH SIDES AT ONE TIME, HE SCREWED IN ONE BY ONE. PATIENT STATUS IS STABLE. THE PROCEDURE WAS DELAYED LESS THAN 30 MINUTES. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) PRIME STYLET DEPTH ADJUSTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 10251291 ↗
• MalfunctionFeb 21, 2020Material Deformation; Material Deformation

  CONCOMITANT DEVICE REPORTED: VIPER PRIME STYLET (PART # 286750200S, LOT # UNKNOWN, QUANTITY 1); THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9742193 ↗
• 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 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 PRIME STYLET DEPTH ADJUSTOR. THIS IS REPORT 6 OF 6 FOR PC-(B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9504612 ↗
• MalfunctionNov 22, 2019Break; Break

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT A VIPER PRIME STYLET ADJUSTER WAS DAMAGED ON (B)(6) 2019, WHEN IT WAS BEING DISASSEMBLED; THE DISTAL END OF THE ADJUSTER HAS BROKEN AWAY. THIS REPORT IS FOR A PRIME STYLET DEPTH ADJUSTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9364298 ↗