VIPER 186731840Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034352183), received between Sep 22, 2020 and Oct 23, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A POSTERIOR FUSION (L2-ILIAC BONE) WAS PERFORMED ON (B)(6) 2021. AFTER THE SURGERY, AN ADJACENT SEGMENT DISEASE WAS CONFIRMED AND THE REMOVAL SURGERY AND PLIF (L1-2) WAS PERFORMED ON (B)(6) 2025. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A THIRTY (30) MINUTE DELAY. THE PATIENT STATUS WAS REPORTED AS STABLE. THIS REPORT CAPTURES THE FIRST PROCEDURE AND ITS CAUSE. THE REMOVAL PROCEDURE IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 23369610 ↗
• InjurySep 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PLIF PROCEDURES (L4/5) FOR TREATING ASD ON (B)(6) 2022. THE EVENT TOOK PLACE IN SEQUENCE AS FOLLOWS: THERE WAS A POSSIBILITY THAT THE SCREW 7.0×40 (UNK), THAT INSERTED TO L5 IN THIS SURGERY WAS LOOSE, SO IT WAS REMOVED. THE SURGEON TRIED TO REPLACE IT WITH THE SCREW 8.0×40 AND TRIED TO INSERT IT BUT WAS UNABLE TO INSERT IT DUE TO RESISTANCE. THE TIP OF THE SCREWDRIVER IN QUESTION WAS BROKEN. THE TIP OF THE SCREWDRIVER GOT CAUGHT IN THE CORE OF THE SCREW 8.0×40, AND THE SURGEON HAD DIFFICULTY REMOVING THE SCREW 8.0×40, BUT HE MANAGED TO DO SO AND THE REMOVAL WAS COMPLETED. THE SURGEON COMMENTED THAT THE REASON FOR THE DIFFICULTY IN INSERTING THE SCREW 8.0×40 WAS THAT THE PATIENT'S BONE WAS QUITE HARD, AND THAT WHEN HE DID NOT TAP THE SCREW 8.0×40 TO BREAK THROUGH ALTHOUGH HE FELT RESISTANCE DURING INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 8X40MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401501 ↗
• InjuryAug 15, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, WHILE PLACING THE LEFT SIDE S1 PEDICLE SCREW THE DISTAL TIP OF THE SCREWDRIVER BROKE OFF IN THE HEAD OF THE SCREW. THE SURGEON ATTEMPTED TO REMOVE IT AND BROKE THE TULIP OFF THE SHANK OF THE SCREW. THE SCREW NEEDED TO BE BURRED DOWN USING A METAL CUTTING BURR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 60 MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS REPORT IS FOR A VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 40MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15224004 ↗
• MalfunctionSep 22, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) AT S1 TREATING SPINAL CANAL STENOSIS ON (B)(6) 2020. THE CONNECTION BETWEEN THE SCREW AND THE SCREWDRIVER BECAME LOOSE DURING SCREW INSERTION. THE SURGEON REATTACHED THEM AND MOVED ON TO REINSERTION, WHICH RESULTED IN THE SAME. THEN, HE FOUND METAL THREAD-LIKE FRAGMENTS IN THE SURGICAL FIELD THAT WERE GENERATED. IT WAS CONFIRMED BY INTRAOPERATIVE IMAGING AND POST-OPERATIVE X-RAY THAT THERE WERE NO FRAGMENTS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT SCREWDRIVER WITH LESS THAN 30-MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 TI CORT FIX 8X40MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567520 ↗