VIPER PRIME 286750034Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034507613), received between Dec 20, 2019 and Feb 19, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION STATED THAT THE EVENT OCCURRED DURING INTRA-OP WITH PATIENT INVOLVEMENT AND WAS STABLE. THE SURGERY WAS SUCCESSFUL. SURGICAL DELAY WAS APPROXIMATELY 15 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412122 ↗
• MalfunctionDec 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CUSTOMER SERVICE TECHNICIAN HAD DIFFICULTY ASSEMBLING VIPER PRIME DRIVERS, THIS COMPLAINT INVOLVES FOUR(4) DEVICES. THIS REPORT IS FOR ONE (1) VIPER PRIME INSERT DRIVE TUBE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040343 ↗
• MalfunctionDec 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CUSTOMER SERVICE TECHNICIAN HAD DIFFICULTY ASSEMBLING VIPER PRIME DRIVERS, THIS COMPLAINT INVOLVES FOUR(4) DEVICES. THIS REPORT IS FOR ONE (1) VIPER PRIME INSERT DRIVE TUBE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040330 ↗
• MalfunctionFeb 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, DURING AN INCOMING INSPECTION IT WAS NOTICED THAT THE TWO INSTRUMENT PARTS WERE VERY HARD TO CONNECT. NO PATIENT IMPACT AND SURGERY IMPACT. THIS REPORT IS FOR ONE (1) VIPER PRIME INSERTER SHAFT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481002 ↗
• 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 INSERT DRIVE TUBE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625283 ↗
• 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 INSERT DRIVE TUBE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11786968 ↗
• MalfunctionOct 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION, THE DISASSEMBLY OF THE VIPER PRIME SCREWDRIVER WAS DIFFICULT TO DISASSEMBLE. POST-DISASSEMBLY, IT WAS DISCOVERED THAT THERE WAS ABRASION ON THE SLEEVE AND SHAFT. NO PATIENT OR PROCEDURE INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) VIPER PRIME INSERT DRIVE TUBE. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 10706228 ↗
• MalfunctionSep 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  UPDATED CONCOMITANT DEVICES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10534890 ↗
• MalfunctionFeb 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9742188 ↗
• 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 VIPER PRIME INSERT DRIVE TUBE. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9504549 ↗