VIPER PRIME 286750100Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 10705034507750), received between Jan 21, 2019 and Jun 10, 2026 — classified as 83 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (66 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 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE SURGERY, SURGEON COULD NOT TIGHTEN THE ZIPFIX. ANOTHER NINE DEVICES WERE USED TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY REPORTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456054 ↗
• MalfunctionJun 10, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE SURGERY, SURGEON COULD NOT TIGHTEN THE ZIPFIX. ANOTHER NINE DEVICES WERE USED TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY REPORTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456033 ↗
• MalfunctionJun 10, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE SURGERY, SURGEON COULD NOT TIGHTEN THE ZIPFIX. ANOTHER NINE DEVICES WERE USED TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY REPORTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455708 ↗
• MalfunctionJun 10, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE SURGERY, SURGEON COULD NOT TIGHTEN THE ZIPFIX. ANOTHER NINE DEVICES WERE USED TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY REPORTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455703 ↗
• MalfunctionJun 8, 2026Material Integrity Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR SPINAL FUSION (L2-L5) ON (B)(6) 2026. AFTER L2-L5 3-SEGMENT LIF (NON-SYNTHES), PPS FIXATION OF L2-L5 IN THE PRONE POSITION, CEMENT INJECTION WAS PLANNED CRANIOCAUDALLY. PROCEDURE USED VIPERPRIME SCREW, VIPERPRIME FENESTRATED SCREW, CEMENT INJECTION: L2: 1CC/R: 1.2CC, L5: 1CC. A METALLIC SOUND, DIFFERENT FROM THE USUAL, RANG OUT RIGHT BEFORE CUTTING THE TORQUE WHEN FIXING THE SET SCREW AND FINAL FIXING WAS PERFORMED AFTER SCREWING, CEMENT INJECTION, COMPRESSION, RODDING. THE TIP OF THE SET SCREWDRIVER BROKE, AND IT REMAINED IN THE BODY. IT WAS NOT REMOVED BY THE SURGEON¿S DECISION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES SURGICAL DELAY. THE PATIENT'S CONDITION AFTER SURGERY WAS NOT CONFIRMED. THE PATIENT HAS METAL ALLERGY, AND THE SALES REP HAS CHECKED THE SET SCREW DRIVER¿S MATERIAL AND SHARED INFORMATION WITH NURSES AND DOCTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430840 ↗
• MalfunctionApr 28, 2026Calibration Problem

  IT WAS REPORTED THAT VIPER PRIME TORQUE HANDLE FAILED TORQUE TESTING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017057 ↗
• MalfunctionApr 20, 2026Calibration Problem

  IT WAS REPORTED THE INSTRUMENT WAS FOUND TO BE OUT OF TOLERANCE WHEN WE DID AN ON SITE TEST. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924616 ↗
• MalfunctionFeb 18, 2026Calibration Problem

  IT WAS REPORTED THAT THE TORQUE FAILED THE TORQUE TEST DURING INSPECTION AT THE LOCAL WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377773 ↗
• MalfunctionFeb 2, 2026Calibration Problem

  IT WAS REPORTED THE DEVICE DIDN'T PASS THE TORQUE IN THE INSPECTION. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24237263 ↗
• MalfunctionJan 28, 2026Calibration Problem

  INVALID TORQUE. THIS WAS DISCOVERED DURING INSPECTION AT THE LOCAL WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201976 ↗
• MalfunctionDec 17, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE INSTRUMENT DID NOT PASS TORQUE TEST AT THE INSPECTION AT LOCAL WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830777 ↗
• MalfunctionDec 16, 2025Calibration Problem; Calibration Problem

  TORQUE FAILED TORQUE TEST (VALUES OUT OF SPECIFICATION) DURING TESTING AT THE LOCAL WAREHOUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817050 ↗
• MalfunctionNov 20, 2025Calibration Problem; Calibration Problem

  TORQUE FOUND TO BE OUT OF TOLERANCE WHEN AN ON-SITE TEST WAS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609425 ↗
• MalfunctionOct 28, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE HANDLE OVERTORQUED DURING SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402140 ↗
• MalfunctionMay 1, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING VIPER PRIME CASE, DURING THE FINAL TIGHTENING OF THE SET SCREWS, THE TORQUE HANDLE WAS MAKING A CONSISTENT SOUND WHEN SET SCREWS WERE BEING TIGHTENED. WHEN ONE OF THE SET SCREWS DID ¿TORQUE ¿ IT WAS STILL LOOSE AND REQUIRED TIGHTENING AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 21943006 ↗
• MalfunctionNov 6, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, AN ON SITE TEST WAS PERFORMED AND DIDN¿T INVOLVE ANY PATIENT. DECOM WAS PRESENT AND ALSO THE FAIL TEST SHEET IS PRESENT. DEVICE FAILURE MEASUREMENT: 88.016 DEVICE SPECIFICATION MEASUREMENT: 72.00-88.00. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622577 ↗
• MalfunctionSep 6, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AUGUST 13, 2024 DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE SITE, IT WAS OBSERVED THAT THE TORQUE HANDLE HAD BEEN FOUND TO BE OUT OF SPECIFICATION; THE TORQUE HAD TESTED HIGH. THERE HAD BEEN NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20159200 ↗
• MalfunctionSep 5, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL IT WAS OBSERVED THAT 80 IN.LBF T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) VIPER PRIME TORQUE HANDLE FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148319 ↗
• MalfunctionSep 4, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT ITEM WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE VIPER PRIME TORQUE HANDLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134058 ↗
• MalfunctionSep 3, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT, 80 IN.LBF T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED AND NO REPLACEMENT PRODUCT IS REQUIRED. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) VIPER PRIME TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129876 ↗
• MalfunctionAug 20, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON JULY 19,2024, IT WAS OBSERVED THAT A 80 IN. LBF T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A VIPER PRIME TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007328 ↗
• MalfunctionAug 15, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE SITE IT WAS OBSERVED THAT 80 IN.LBF T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED TO THE REPAIR SITE. NO REPLACEMENT PRODUCT IS REQUIRED, AND NO SHIPPING LABEL IS REQUIRED FOR THE PRODUCT RETURN. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) VIPER PRIME TORQUE HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996909 ↗
• MalfunctionAug 15, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON JULY 18, 2024, THE ITEM WAS OBSERVED TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE VIPER PRIME TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996134 ↗
• MalfunctionAug 14, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON JULY 17, 2024, IT WAS OBSERVED THAT A TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A VIPER PRIME TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987722 ↗
• MalfunctionAug 14, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON JULY 17, 2024, IT WAS OBSERVED THAT THE T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A VIPER PRIME TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19985729 ↗