VIPER 279704401Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034438191), received between Mar 21, 2018 and May 29, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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.

• MalfunctionMay 29, 2026Material Twisted/Bent

  IT WAS REPORTED THE DEVICE TIP WAS WORN DOWN. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330796 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING POST OP INSPECTION, IT WAS FOUND THAT INSTRUMENTS WERE BROKEN. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821853 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT ON NOVEMBER 19, 2024 DURING POST OP INSPECTION, IT WAS FOUND THAT INSTRUMENTS WERE BROKEN. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821495 ↗
• MalfunctionDec 13, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE TIPS OF THE SCREWDRIVERS IN QUESTION WERE FOUND WORN DOWN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A VIPER SYSTEM LAG POLYAXIAL SCREW DRIVER 5.5 T27. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319452 ↗
• MalfunctionDec 13, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE TIPS OF THE SCREWDRIVERS IN QUESTION WERE FOUND WORN DOWN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A VIPER SYSTEM LAG POLYAXIAL SCREW DRIVER 5.5 T27. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319440 ↗
• MalfunctionAug 15, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, AS PART OF DR. (B)(6) OF HIS REVISION FROM (B)(6) 2018 (PART 1) HE EXPOSED THE PATIENT FROM T10-ILIUM AND AS PLANNED REVISED THE PREVIOUS CONSTRUCT WITH NEW RODS AND EXPEDIUM SINGLE INNER SCREWS (REMOVED FOR POSTERIOR RELEASE/ CORONAL DEFORMITY, (B)(4)). ON (B)(6) 2018 DURING THE INITIAL REVISION OF THE CONSTRUCT, DR. (B)(6) INSPECTED THE 9X100MM ILIAC SCREW ON THE RIGHT AND DECIDED TO REPLACE IT WITH A 10X100MM. IN DOING SO, HE REMOVED THE SCREW, TAPPED WITH A 10MM VIPER SAI TAP TO 100MM. UPON INSERTION OF THE 10X100MM SCREW, HE BROKE THE VIPER SAI MIS DRIVER SCREW TIP ((B)(4)) UPON MEETING AN EXTREME AMOUNT OF RESISTANCE FROM DENSE, PELVIC BONE. THE TIP OF THE SCREW WAS LODGED IN THE T27 FITTING OF THE FULLY THREADED SAI SCREW. AT THE TIME ((B)(6) 2018), HE DECIDED TO FIX THE SCREW ON (B)(6) 2018. ON (B)(6) 2018, UPON EXPOSING THE PATIENT, HE NOTICED THAT THE SCREWDRIVER TIP THAT HAD PREVIOUSLY BEEN STUCK IN THE T27 FITTING OF THE SCREW HAD LOOSENED AND WAS EASILY OBTAINED. THE TIP WAS REMOVED AND DR. (B)(6) ATTACHED A BRAND NEW VIPER SAI MIS SCREWDRIVER TO THE 10X100MM SCREW IN AN ATTEMPT TO REMOVE THE SCREW. DR. (B)(6) IMMEDIATELY MET RESIST

  Patient problems: Not Applicable

  MAUDE report 7785624 ↗
• MalfunctionAug 15, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, AS PART OF DR. (B)(6) OF HIS REVISION FROM (B)(6) 2018 (PART 1) HE EXPOSED THE PATIENT FROM T10-ILIUM AND AS PLANNED REVISED THE PREVIOUS CONSTRUCT WITH NEW RODS AND EXPEDIUM SINGLE INNER SCREWS (REMOVED FOR POSTERIOR RELEASE/ CORONAL DEFORMITY, (B)(4). ON (B)(6) 2018 DURING THE INITIAL REVISION OF THE CONSTRUCT, DR. (B)(6) INSPECTED THE 9 X 100 MM ILIAC SCREW ON THE RIGHT AND DECIDED TO REPLACE IT WITH A 10 X 100 MM. IN DOING SO, HE REMOVED THE SCREW, TAPPED WITH A 10 MM VIPER SAI TAP TO 100 MM. UPON INSERTION OF THE 10 X 100 MM SCREW, HE BROKE THE VIPER SAI MIS DRIVER SCREW TIP (B)(4) UPON MEETING AN EXTREME AMOUNT OF RESISTANCE FROM DENSE, PELVIC BONE. THE TIP OF THE SCREW WAS LODGED IN THE T27 FITTING OF THE FULLY THREADED SAI SCREW. AT THE TIME ((B)(6) 2018), HE DECIDED TO FIX THE SCREW ON (B)(6) 2018. ON (B)(6) 2018, UPON EXPOSING THE PATIENT, HE NOTICED THAT THE SCREWDRIVER TIP THAT HAD PREVIOUSLY BEEN STUCK IN THE T27 FITTING OF THE SCREW HAD LOOSENED AND WAS EASILY OBTAINED. THE TIP WAS REMOVED AND DR. (B)(6) ATTACHED A BRAND NEW VIPER SAI MIS SCREWDRIVER TO THE 10 X 100 MM SCREW IN AN ATTEMPT TO REMOVE THE SCREW. DR. (B)(6) IMMEDIATELY

  Patient problems: Not Applicable

  MAUDE report 7784882 ↗
• MalfunctionAug 15, 2018Break; Break

  IT WAS REPORTED THAT DR. MORRISON WAS REVISING A 9X100MM FULLY THREADED ILIAC SCREW ON (B)(6) 2018. THE IMPLANT WAS LOOSE WHICH REQUIRED IT TO BE REPLACED. DR. (B)(6) SUCCESSFULLY REMOVED A 9X100MM FULLY THREADED SAI SCREW ((B)(4)) ON THE RIGHT. HE THEN PROCEEDED TO USE A 10MM SAI TAP AND TAPPED THE FULL LENGTH OF 100MM IN THE SAME SCREW HOLE WHERE HE REMOVED THE 9X100MM SCREW. HE THEN PLACED THE NEW 10X100MM SCREW. AT 80MM HE BEGAN TO SEE INCREASED RESISTANCE. HE THEN TOOK A T-HANDLE AND ATTACHED IT TO THE SAI SCREWDRIVER. UPON 5MM OF ADDITIONAL INSERTION, THE TIP OF THE SCREWDRIVER BROKE (15MM OF SCREW THREADS EXPOSED). HE TRIED TO REMOVE THE SCREW BY ¿HELICOPTERING¿ THE SCREW OUT USING A CUSTOM DEVICE. HE WAS UNABLE TO REMOVE THE SCREW. HE DECIDED TO WAIT TILL FRIDAY, (B)(6) 2018 TO REMOVE THE SCREW AND REPLACE IT. THE (B)(6) 2018 REVISION WAS ALREADY SCHEDULED FOR IMPLANTING RODS AND NEW EXPEDIUM INNER SCREWS. PATIENT CONSEQUENCE? :YES PATIENT CONSEQUENCE DESCRIPTION:ADDITIONAL ANESTHESIA INCURRED IN ATTEMPT TO REMOVE THE SCREW (FROM THE BROKEN SCREWDRIVER. 15 MINUTES. ACTION TAKEN FOR PROCEDURE:REVISION 7/27/2018. SURGERY WAS ALREADY PLANNED FOR PUTTING NEW RODS AND SET SCREWS

  Patient problems: Not Applicable

  MAUDE report 7784240 ↗
• MalfunctionMar 21, 2018Break; Break

  THE PATIENT RETURNED TO DR. (B)(6) CLINIC AND PRESENTED WITH PAIN STEMMING FROM THE LOWER LUMBAR REGION AFTER A T3-ILIUM POSTERIOR LATERAL FUSION ¿ L2 PSO (FOR PAIN AND KYPHOSIS, ORIGINAL DOS (B)(6) 2016) . USING RADIOGRAPHIC CT AND X-RAY DR. (B)(6) NOTICED THE PATIENT HAD FRACTURED HER RODS BILATERAL IN THE L4-S1 REGION, MOST LIKELY AS A RESULT OF PSEUDARTHROSIS. AFTER CONSERVATIVE THERAPY DR. (B)(6) AND THE PATIENT AGREED ON A REVISION SURGERY. THE REVISION SURGERY WOULD ENTAIL INTRAOPERATIVE INSPECTION HARDWARE INCLUDING POTENTIAL SCREW LOOSENING AND HARDWARE FAILURE THROUGHOUT THE CONSTRUCT AS WELL AS POTENTIAL PSEUDARTHROSIS. ON (B)(6) 2018 DR. (B)(6) BROUGHT THE PATIENT TO THE OPERATING ROOM FOR THE T3-ILIUM REVISION SURGERY. UPON FULL EXPOSURE OF T3-ILIUM, DR. (B)(6) REMOVED THE EXPEDIUM INNER SET SCREWS OF THE ENTIRE CONSTRUCT. HE THEN PROCEEDED TO REMOVE THE VIPER COCR 5.5 X 480 MM RODS. UPON REMOVAL IT WAS CONFIRMED THAT THE RODS HAD FRACTURED BILATERALLY AT THE L4-S1 REGION. IT WAS ALSO CONFIRMED THAT THERE WAS MOVEMENT THROUGHOUT THOSE SEGMENTS OF THE SPINE. THIS CONFIRMED THE INITIAL ASSUMPTION OF NON-UNION THROUGH THE LEVELS L4-L5 AND L5-S1. DR. (B)(6) CHECKED THE PUR

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7357308 ↗
• MalfunctionMar 21, 2018Break; Break

  THE PATIENT RETURNED TO DR. (B)(6) CLINIC AND PRESENTED WITH PAIN STEMMING FROM THE LOWER LUMBAR REGION AFTER A T3-ILIUM POSTERIOR LATERAL FUSION ¿ L2 PSO (FOR PAIN AND KYPHOSIS, ORIGINAL DOS (B)(6) 2016) . USING RADIOGRAPHIC CT AND X-RAY DR. (B)(6) NOTICED THE PATIENT HAD FRACTURED HER RODS BILATERAL IN THE L4-S1 REGION, MOST LIKELY AS A RESULT OF PSEUDARTHROSIS. AFTER CONSERVATIVE THERAPY DR. (B)(6) AND THE PATIENT AGREED ON A REVISION SURGERY. THE REVISION SURGERY WOULD ENTAIL INTRAOPERATIVE INSPECTION HARDWARE INCLUDING POTENTIAL SCREW LOOSENING AND HARDWARE FAILURE THROUGHOUT THE CONSTRUCT AS WELL AS POTENTIAL PSEUDARTHROSIS. ON (B)(6) 2018 DR. (B)(6) BROUGHT THE PATIENT TO THE OPERATING ROOM FOR THE T3-ILIUM REVISION SURGERY. UPON FULL EXPOSURE OF T3-ILIUM, DR. (B)(6) REMOVED THE EXPEDIUM INNER SET SCREWS OF THE ENTIRE CONSTRUCT. HE THEN PROCEEDED TO REMOVE THE VIPER COCR 5.5 X 480 MM RODS. UPON REMOVAL IT WAS CONFIRMED THAT THE RODS HAD FRACTURED BILATERALLY AT THE L4-S1 REGION. IT WAS ALSO CONFIRMED THAT THERE WAS MOVEMENT THROUGHOUT THOSE SEGMENTS OF THE SPINE. THIS CONFIRMED THE INITIAL ASSUMPTION OF NON-UNION THROUGH THE LEVELS L4-L5 AND L5-S1. DR. (B)(6) CHECKED THE PUR

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7357272 ↗