VIPER 186760040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034129198), received between Jan 14, 2020 and Feb 10, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionFeb 10, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT IS NOT POSSIBLE TO PLACE INSERTION SLEEVE (B)(4) OVER THE SCREW EXTENSIONS PRIOR TO INSERTION IN PATIENT. WHEN THE EXTENSIONS ON THE SCREWS ARE INSERTED APPROXIMATELY 1 CM THE SCREW GETS STUCK IN THE INSERTION SLEEVE. THIS HAS BEEN TESTED ON THE ACCOUNT MANAGERS OWN DEMO SLEEVE. SURGERY WAS PERFORMED AS PLANNED. NO CONSEQUENCE FOR PATIENT. THIS REPORT IS FOR ONE (1) MIS CANNULATED X-TAB 6X40MM TI. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16352993 ↗
• MalfunctionJul 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. TABS ON THE SCREW IN QUESTION WERE REMOVED PRIOR TO ROD DEPLOYMENT. IN ORDER THE MAKE A MINOR ADJUSTMENT IN SCREW POSITIONING, HE ATTACHED THE EXPEDIUM QC DRIVER (UNK) TO THE SCREW IN QUESTION AND FINISHED SCREW HEIGHT ADJUSTMENT. HOWEVER, HE WAS NOT ABLE TO DETACHED THE DRIVER FROM THE SCREW. FINALLY, THE SCREW IN QUESTION WAS REMOVED FROM THE LESION TOGETHER WITH THE DRIVER. THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) MIS CANNULATED X-TAB 6X40MM TI THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075084 ↗
• MalfunctionJan 14, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) CANNULATED EXTENDED TAB POLY SCREW WAS BROKEN OFF. THE PROCEDURE AND PATIENT INVOLVEMENT WERE UNKNOWN. THIS REPORT IS FOR ONE (1) MIS CANNULATED X-TAB 6X40MM TI. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586459 ↗