VIPER 186731525Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034351599), received between Apr 25, 2019 and Jan 11, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. AFTER THE SURGERY ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON THE CONCAVE SIDE. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023. THE SET SCREWS ON T2, 3, 4, AND 5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT AND REMOVED. FOUR UNIPLANAR SCREWS WERE REMOVED ON THE LEFT OF T2-T5. THE AFFECTED AREA WAS WASHED, AND A HOOK WAS PLACED ON T2. A SIDE-SIDE CONNECTOR WAS INSTALLED AT THE UPPER END OF T5, AND TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 5 X 25MM. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18491237 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 09-(B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. AFTER THE SURGERY ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON THE CONCAVE SIDE. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023. THE SET SCREWS ON T2, 3, 4, AND 5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT AND REMOVED. FOUR UNIPLANAR SCREWS WERE REMOVED ON THE LEFT OF T2-T5. THE AFFECTED AREA WAS WASHED, AND A HOOK WAS PLACED ON T2. A SIDE-SIDE CONNECTOR WAS INSTALLED AT THE UPPER END OF T5, AND TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 5 X 25MM. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18491235 ↗
• MalfunctionApr 25, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE POSTERIOR THORACIC FUSION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO NERVE COMPRESSION DUE TO MALIGNANT SPINE METASTASIS. DURING THE SURGERY, AFTER THE SURGEON IMPLANTED THE SCREW INTO PATIENT¿S THORACIC SPINE, WHEN THE SURGEON TRIED TO IMPLANT THE ROD (P/N AND LOT# WERE UNKNOWN), IT WAS REPORTED THAT THE SURGEON RECOGNIZED THAT THE COLLET PART AT THE SCREW HEAD WAS TWISTED AND BROKEN. THE IMPLANTED SCREW WAS REVISED TO ALTERNATIVE SCREW, AND COMPLETED THE SURGERY. THERE WAS NO INFORMATION OF SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8550028 ↗