VIPER PRIME 186750430SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034529929), received between Jun 30, 2025 and Jun 30, 2025 — classified as 4 malfunctions.

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

• MalfunctionJun 30, 2025Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. IN THE SURGERY, USING THE GUIDEWIRE, THE SURGEON FELT A SLIGHT CATCH WHILE ATTEMPTING TO INSERT THE SCREW. THE SURGEON DISCONTINUED SCREW INSERTION BECAUSE THE TIP OF THE SCREW MAY HAVE BECOME ENTANGLED WITH THE GUIDEWIRE. AFTER CHECKING THE GUIDEWIRE AND SCREW, IT WAS FOUND THAT THE GUIDEWIRE WAS BENT, SO THE GUIDEWIRE WAS CHANGED FOR A NEW ONE. THE SURGEON WAS CONCERNED ABOUT THE CONDITION OF THE SCREW TIP AND ASKED THE SALES REP WHETHER IT COULD BE INSTALLED PROPERLY. THE SALES REP WAS NOT SURE, SO THE NEW SCREW WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366908 ↗
• MalfunctionJun 30, 2025Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. IN THE SURGERY, USING THE GUIDEWIRE, THE SURGEON FELT A SLIGHT CATCH WHILE ATTEMPTING TO INSERT THE SCREW. THE SURGEON DISCONTINUED SCREW INSERTION BECAUSE THE TIP OF THE SCREW MAY HAVE BECOME ENTANGLED WITH THE GUIDEWIRE. AFTER CHECKING THE GUIDEWIRE AND SCREW, IT WAS FOUND THAT THE GUIDEWIRE WAS BENT, SO THE GUIDEWIRE WAS CHANGED FOR A NEW ONE. THE SURGEON WAS CONCERNED ABOUT THE CONDITION OF THE SCREW TIP AND ASKED THE SALES REP WHETHER IT COULD BE INSTALLED PROPERLY. THE SALES REP WAS NOT SURE, SO THE NEW SCREW WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366902 ↗
• MalfunctionJun 30, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. IN THE SURGERY, THE NURSE FOUND IT DIFFICULT TO ATTACH THE SCREW IN QUESTION, SO THE SALES REP EXPLAINED TO THE NURSE THAT SHE SHOULD ATTACH THE SCREW BY PUSHING IT IN WHILE ALIGNING THE CENTER AXIS, AND THE NURSE ATTACHED THE SCREW IN QUESTION. HOWEVER, WHEN THE SURGEON TRIED TO INSERT THE SCREW, THE AXIS APPEARED TO BE UNSTABLE. THEREFORE, THE SCREW WAS REATTACHED, BUT THEY WERE STILL DIFFICULT TO ATTACH. WHEN ANOTHER SCREW WAS ATTACHED, IT WENT SMOOTHLY, SO THE SCREW WAS NOT USED, AND ANOTHER SCREW WAS USED INSTEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366710 ↗
• MalfunctionJun 30, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. IN THE SURGERY, THE NURSE FOUND IT DIFFICULT TO ATTACH THE SCREW IN QUESTION, SO THE SALES REP EXPLAINED TO THE NURSE THAT SHE SHOULD ATTACH THE SCREW BY PUSHING IT IN WHILE ALIGNING THE CENTER AXIS, AND THE NURSE ATTACHED THE SCREW IN QUESTION. HOWEVER, WHEN THE SURGEON TRIED TO INSERT THE SCREW, THE AXIS APPEARED TO BE UNSTABLE. THEREFORE, THE SCREW WAS REATTACHED, BUT THEY WERE STILL DIFFICULT TO ATTACH. WHEN ANOTHER SCREW WAS ATTACHED, IT WENT SMOOTHLY, SO THE SCREW WAS NOT USED, AND ANOTHER SCREW WAS USED INSTEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366706 ↗