VIPER 186715850Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034122755), received between Apr 16, 2018 and Jan 5, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

8 other recalls cover devices cleared under the same FDA submission (K101993); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: ADJACENT SEGMENT PATHOLOGY, INSTABILITY COMPLICATION TIME/INTERVENTION. REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE EXPEDIUM /OTHER AND MOSS MIAMI SI /OTHER AND VIPER PRODUCTS (VIPER POLY SCREW 8X50MM TI (B)(4).

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 18453447 ↗
• MalfunctionMay 24, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THE SURGEON WAS INSERTING THE SCREW INTO THE VERTEBRAL BODY WHEN THE HEAD OF THE SCREW BROKE OFF AND DISENGAGED. THE FELLOW PROCEEDED TO INSERT HIS SCREW AND THE SAME EXACT THING HAPPENED. IN BOTH INSTANCES, THE PEDICLES THEY WERE INSERTING THE SCREWS INTO HAD PREVIOUS HARDWARE THAT HAD BEEN REMOVED. THE SURGEON/FELLOW DID NOT TAP. THIS REPORT IS FOR ONE (1) VIPER POLY SCREW 8X50 MM TI. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492019 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT DURING POSTERIOR SPINAL FUSION SURGERY ON (B)(6) 2021, THE SCREW HEAD ¿TULIP¿ PART OF SCREW POPPED OFF AS THE SURGEON WAS INSERTING THE SCREW. THE SURGEON WAS USING 8.0X50MM SCREW AT THE LEFT T11 PEDICLE. THE SURGEON USES CUSTOM AWLS TO ACCESS THE PEDICLE; DOES NOT TAP AND PROCEEDS DIRECTLY FROM THE AWL TO SCREW INSERTION. THERE WERE NO FRAGMENTS GENERATED. THE SURGEON REMOVED THE BROKEN SCREW REPLACED IT WITH A SMALLER DIAMETER SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A VIPER POLY SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739725 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN SURGERY WHILE PLACING A SCREW AT THE L4 VERTEBRAL BODY, THE SURGEON WAS TURNING THE HANDLE AND ENCOUNTERED A HIGHER INSERTION TORQUE THAN NORMAL. THE SCREW HEAD THEN DISENGAGED FROM THE SCREW SHANK AND CAME OFF. IT WAS ADVISED THAT THE SURGEON TAP THE BONE PRIOR TO SCREW PLACEMENT, HOWEVER HE WAS SIMPLY REPLACING A SCREW THAT HAD BEEN REMOVED AT THAT SITE PREVIOUSLY AND DECIDED AGAINST TAPPING. NO FRAGMENTS WERE GENERATED. SCREW SHANK WAS REMOVED USING A DIFFERENT SCREWDRIVER. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) VIPER SYSTEM POLYAXIAL SCREW 5.5 X 8 X 50MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737277 ↗
• InjuryFeb 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THE SURGEON COMPLETED LAMINECTOMY REVISION SURGERY. REVISION WAS PERFORMED AS THE PATIENT NEEDED A PROCEDURE DONE AND THE IMPLANTS WERE IN THE WAY TO ACHIEVE THE SURGICAL GOAL FOR HIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11296329 ↗
• MalfunctionApr 16, 2018Disassembly; Disassembly

  IT WAS REPORTED DOCTOR WAS IMPLANTING 8X50 VIPER SCREW. HE STOPPED TO TAKE FLUORO PICTURE TO CONFIRM ALL WAS OK WITH PLACEMENT. STARTED TO ADVANCE SCREW FURTHER DOWN AND SCREW HEAD POPPED OFF. THE RING BETWEEN SCREW HEAD AND SCREW SHANK WAS BROKEN. HAD TO RETRIEVE THOSE BROKEN METAL FRAGMENTS AND TAKE SCREW SHAFT OUT. FIFTEEN MINUTES DELAY REPORTED.

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

  MAUDE report 7432336 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101993. One submission often covers many models, so check the product and lot details in each record.

• Z-0708-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.
• Z-0710-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.
• Z-0707-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.
• Z-0709-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.
• Z-0712-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
• Z-0705-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.
• Z-0706-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.
• Z-0713-2013 · Nov 7, 2012 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.