VIPER 186731650Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034351841), received between Mar 9, 2020 and Aug 29, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED A POSTERIOR SPINAL FUSION (LUMBAR) FOR SPINAL CANAL STENOSIS OCCURRED ON (B)(6) 2024, WITH THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON APRIL 23, 2025, THE SALES REP WAS INFORMED BY THE SURGEON THAT THE SCREW HAD BROKEN. CURRENTLY, THE PATIENT HAS NO SYMPTOMS. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923481 ↗
• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED A POSTERIOR SPINAL FUSION (LUMBAR) FOR SPINAL CANAL STENOSIS OCCURRED ON (B)(6) 2024, WITH THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON APRIL 23, 2025, THE SALES REP WAS INFORMED BY THE SURGEON THAT THE SCREW HAD BROKEN. CURRENTLY, THE PATIENT HAS NO SYMPTOMS. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922456 ↗
• MalfunctionNov 4, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION (L3 TO L4) FOR ADJACENT SEGMENT DISEASE ON (B)(6), 2022, THE SCREW HEAD WAS DULL WHEN THE NURSE TRIED TO ATTACH IT TO A SCREWDRIVER. THE SURGEON DECIDED TO USE A NEW SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 6 X 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725676 ↗
• MalfunctionDec 22, 2020Device Slipped; Device Slipped

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT THE PATIENT UNDERWENT FOR A PLIF (POSTERIOR LUMBAR INTERBODY FUSION) AT L4 LEFT SURGERY. DURING THE SURGERY, WHEN SURGEON WAS TIGHTENING THE SCREW, SCREW WAS FELT MUCH TIGHTNESS. THE SCREW WAS NOT SITUATED EVENLY. SURGEON REMOVED THE SCREW AND FOUND SOME LOOSE AREA IN THE SCREWHEAD. THE PROCEDURE WAS COMPLETED WITH 30 MINUTES DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 5.5 TI CORT FIX 6X50MM. THIS REPORT IS 1 OF 1 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11060005 ↗
• MalfunctionMay 5, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT SEVERAL 5.5 MM TI CORT FIX 6X50MM WERE DAMAGED. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10025221 ↗
• MalfunctionMay 5, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT SEVERAL 5.5 MM TI CORT FIX 6X50MM WERE DAMAGED. THERE WAS NO KNOWN PATIENT, OR HOSPITAL INVOLVEMENT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10025162 ↗
• MalfunctionMay 5, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT SEVERAL 5.5 MM TI CORT FIX 6X50MM WERE DAMAGED. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10025129 ↗
• InjuryMar 9, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON PERFORMED A REVISION OF CONCORDE LIFT CAGE AND A BROKEN CORTICAL FIX SCREW. THE SURGEON REPLACED THE CAGE AND LEFT THE REMAINING SCREW SHANK IN THE PATIENT AFTER CONFIRMING IT WAS FULLY BURIED IN THE BODY OF L3. THEY BELIEVE THE CAGE LOST SOME HEIGHT AND FAILED TO FUSE. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICES REPORTED: CONCORDE LIFT, CONVEX 9X21 (PART#: 197809021C, LOT#: 203128, QUANTITY#: 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9805847 ↗