VIPER 186727850Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034282794), received between Feb 26, 2018 and Jan 8, 2024 — classified as 7 injuries, 2 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: 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: IMPLANT FAILURE, IMPLANT MALPOSITION, OTHER. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 50MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18463500 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: 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: DURAL LESION, ADJACENT SEGMENT PATHOLOGY, NEUROCOMPRESSION COMPLICATION TIME/INTERVENTION INTRAOPERATIVE, REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 50MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Nerve Damage; Osteolysis; Unspecified Tissue Injury

  MAUDE report 18454132 ↗
• InjuryAug 17, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE S1 SCREWS IN QUESTION HAD FRACTURED INSIDE OF THE PATIENT. REVISION PROCEDURE WAS PERFORMED ON UNKNOWN DATE IN 2023. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17564099 ↗
• MalfunctionAug 17, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, HE HAS SEEN AN INCREASE OF S1 SCREWS FRACTURING IN HIS PATIENTS. THESE SCREWS WERE IMPLANTED IN HIS PATIENTS 1-2 YEARS AGO. THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 50MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17563909 ↗
• InjuryMar 1, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A SURGERY. DURING THE SURGERY, THE POLYAXIAL HEAD OF THE SCREW BROKE OFF AND THE TIP OF THE SCREWDRIVER BROKE TOO. THE PATIENT WAS STRONG AND VERY STABLE WITH OSTEOCHONDROSIS AND SCLEROSED FACET JOINT. THE CHOSEN SCREWS THAT WERE TOO THICK. THE BROKEN SCREW COULD BE REMOVED FULLY. THE PREDRILLED HOLE USED FOR ANOTHER SCREW AND COULD COMPLETE THE SURGERY SUCCESSFULLY WITH A POSITIVE PATIENT OUTCOME. THERE WAS A 20 MINUTES SURGICAL DELAY REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) UNK - PLATES THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395979 ↗
• InjuryJun 4, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT RECEIVED RE-SPONDYLODESIS AND WAS TREATED WITH EXPEDIUM SI FROM L3-S1 AND EXPEDIUM DI IN S1. DUE TO THE POOR SCREW POSITION, ALL EXPEDIUM SCREWS L5 & S1 WERE REMOVED AND REPLACED, AND L2 WAS ALSO SUPPLIED BECAUSE OF CONNECTION DEGENERATION. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME WAS OKAY. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10121464 ↗
• InjuryMar 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DUE TO BAD SCREW PLACEMENT OF A SPINAL FUSION SURGERY THE SPINAL FUSION WAS REVISED. AFTER THE S1 SCREW WAS PLACED WITH A K-WIRE THE SURGEON TRIED TO REMOVE THE K-WIRE WHICH WAS NOT SUCCESSFUL. THE TORX TIP OF THE VIPER SCREWDRIVER WAS BROKEN OFF AND COULD NOT BE REMOVED FROM THE SCREW HEAD. SURGEON LEFT THE K-WIRE IN THE PEDICLE OF THE DISC UNTIL THE SCREW WAS TIGHTENED. PATIENT HAD STRONG PEDICLE AND A HIGH BONE QUALITY/DENSITY. NO THREADING WAS DONE PRE-SCREW PLACEMENT. THE K-WIRE REMAINED IN THE SCREW BUT WAS SHORTENED IN ORDER TO TIGHTEN THE EXPEDIUM ROD AND INNIE USING A TORQUE SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCE TO THE PATIENT. THERE WAS A SURGICAL DELAY OF FIFTEEN MINUTES. CONCOMITANT DEVICE REPORTED: UNKNOWN K-WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN INNIE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 50MM. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS COMPLAINT WILL CAPTURE THE INTRA

  Patient problems: Foreign Body In Patient

  MAUDE report 9819998 ↗
• InjuryMar 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, AFTER TAPPING WITH A 7.0 TAP, THE CUSTOMER PLACED AN 8.0 VIPER FENESTRATED SCREW. AS HE WAS NEARING THE END OF INSERTION THE SCREWDRIVER TIP SNAPPED OFF AND REMAINED IN THE SCREW SHANK INTERFACE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO REMOVE THE BROKEN TIP, OTHER REMOVAL STRATEGIES WERE UNSUCCESSFULLY USED TO REMOVE THE ENTIRE IMPLANT. ULTIMATELY THE SURGEON CHOSE TO CUT THE HEAD OFF THE SCREW AND LEAVE THE REMAINING SCREW SHANK IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF 60 MINUTES. PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 02 OF 02 OF (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9779910 ↗
• MalfunctionFeb 26, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, THE POLYAXIAL HEAD LOOSENED FROM THE SCREW SHAFT INTRAOPERATIVELY. NO PATIENT HARM AND NO SURGERY DELAY REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7297118 ↗