VIPER 186715650Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034122366), received between Oct 26, 2017 and Jan 5, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2024Migration; Migration

  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, INSTABILITY, NEUROCOMPRESSION, OTHER COMPLICATION TIME/INTERVENTION REPEAT SURGERY. THIS REPORT IS FOR ONE (1) MIS CANN POLY SCW 6X50MM,TI . THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; Joint Laxity; Nerve Damage

  MAUDE report 18450386 ↗
• MalfunctionJun 2, 2023Material Deformation; Material Deformation

  THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049795 ↗
• MalfunctionApr 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THERE WAS A LOSS OF THE SCREW HEAD WHILE JOLLYING INTO THE PEDICLE. THE PEDICLE WAS SCLEROTIC. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. NO ADVERSE PATIENT HARM WAS REPORTED. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED POLYAXIAL SCREW 5.5 X 6 X 50MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943604 ↗
• MalfunctionOct 30, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  4 NUTS BROKE, WHEN WERE SCREWING INTO THE SCREW IN TURN. THEN THE SCREW WAS UNSCREWED AND A THREAD DEFECT WAS DETECTED ON ITSELF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9255164 ↗
• InjuryOct 3, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED ON AN UNKNOWN DATE, PATIENT WAS IN AN ACCIDENT IN (B)(6) AND TAKEN TO A (B)(6) TRAUMA CENTER FOR A T12 COMPRESSION FRACTURE. PATIENT WAS INSTRUMENTED PERCUTANEOUSLY FROM T10-L2 USING DSS VIPER SYSTEM LAST (B)(6) 2019. UPON RETURN TO THE US, PATIENT WAS BENDING AND HEARD/FELT A POP. HE CAME TO THE ER AND IMAGES REVEALED THE HARDWARE HAD DISASSEMBLED. SEVERAL SET SCREWS WERE DISPLACED AND THE ROD HAD COME OUT OF THE SCREW SADDLE. DURING THE REVISION SURGERY, ON (B)(6) 2019, IT WAS FOUND THAT ALL OF THE SET SCREWS WERE LOOSE AND SOME WERE SITTING EXTREMELY PROUD IN THE SCREW SADDLE. HARDWARE WAS REMOVED, REPLACED, AND SUFFICIENTLY LOCKED. THERE WAS A HARDWARE FAILURE AND INFECTION. THERE WAS A PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: VIPER2 STRAIGHT ROD-160MM (PART# 186789160, LOT# UNKNOWN, QUANTITY 1), VIPER2 STRAIGHT ROD-180MM (PART# 186789180, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9153327 ↗
• InjuryOct 3, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED ON AN UNKNOWN DATE, PATIENT WAS IN AN ACCIDENT IN (B)(6) AND TAKEN TO A SWISS TRAUMA CENTER FOR A T12 COMPRESSION FRACTURE. PATIENT WAS INSTRUMENTED PERCUTANEOUSLY FROM T10-L2 USING DSS VIPER SYSTEM LAST (B)(6) 2019. UPON RETURN TO THE US, PATIENT WAS BENDING AND HEARD/FELT A POP. HE CAME TO THE ER AND IMAGES REVEALED THE HARDWARE HAD DISASSEMBLED. SEVERAL SET SCREWS WERE DISPLACED AND THE ROD HAD COME OUT OF THE SCREW SADDLE. DURING THE REVISION SURGERY, ON (B)(6) 2019, IT WAS FOUND THAT ALL OF THE SET SCREWS WERE LOOSE AND SOME WERE SITTING EXTREMELY PROUD IN THE SCREW SADDLE. HARDWARE WAS REMOVED, REPLACED, AND SUFFICIENTLY LOCKED. THERE WAS A HARDWARE FAILURE AND INFECTION. THERE WAS A PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: VIPER2 STRAIGHT ROD-160MM (PART# 186789160, LOT# UNKNOWN, QUANTITY 1), VIPER2 STRAIGHT ROD-180MM (PART# 186789180, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9152166 ↗
• MalfunctionOct 26, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SCREW HEAD WAS LOOSE FROM THE SCREW BODY. THE SCREW HAS NEVER BEEN USED BEFORE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6980968 ↗