VIPER PRIME 286750063Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034507699), received between Sep 22, 2020 and Jun 18, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE OBTURATOR CANNOT BE UNSCREWED; IT IS COLD-WELDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552842 ↗
• MalfunctionApr 30, 2026Material Deformation

  IT WAS REPORTED DURING A MINIMALLY INVASIVE DEGENERATIVE PROCEDURE THAT THE PRIME ROD HOLDER PUSHROD COULD NOT BE EASILY INSERTED INTO THE SHAFT DUE TO A DEFORMED SPRING AT THE DISTAL END, WHICH PREVENTED IT FROM FITTING INTO THE DESIGNED RECESS. THE INSTRUMENT WAS NOT USED, AND A SECOND ROD HOLDER FROM THE SET WAS UTILIZED TO COMPLETE THE SURGERY. THERE WAS NO DELAY IN THE PROCEDURE, AND NO PATIENT CONSEQUENCES OR IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25042761 ↗
• MalfunctionApr 27, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT VIPER PRIME ROD HOLDER SHAFT, VIPER PRIME ROD HOLDER STEM, PRIME ROD HOLDER PUSHROD, AND UNKNOWN RODS WERE INVOLVED IN AN EVENT. DURING A PROCEDURE, AFTER ROD INSTALLATION, THE HOLDER COULD NOT BE REMOVED FROM THE ROD. THE PROBE MARKER WAS PLACED ON THE HOLDER, AND THE HOLDER WAS HAMMERED TO DETACH IT, RESULTING IN THE TIP OF THE PROBE MARKER BENDING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO OBSERVABLE CLINICAL SYMPTOMS OR CHANGES WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998335 ↗
• MalfunctionDec 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INSTRUMENT COULD NOT CONNECT TOGETHER. THE COMPLAINED ARTICLE CONSISTS OF 3 COMPONENTS WITH THE SCREW IDENTIFIED AS THE MOST PROBLEMATIC. THE ERROR WAS NOTICED AFTER DELIVERY, PROMPTING EXAMINATION OF ALL STORED ARTICLES, WHICH EXHIBITED THE SAME ISSUE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772121 ↗
• MalfunctionDec 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INSTRUMENT COULD NOT CONNECT TOGETHER. THE COMPLAINED ARTICLE CONSISTS OF 3 COMPONENTS WITH THE SCREW IDENTIFIED AS THE MOST PROBLEMATIC. THE ERROR WAS NOTICED AFTER DELIVERY, PROMPTING EXAMINATION OF ALL STORED ARTICLES, WHICH EXHIBITED THE SAME ISSUE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772118 ↗
• MalfunctionDec 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INSTRUMENT COULD NOT CONNECT TOGETHER. THE COMPLAINED ARTICLE CONSISTS OF 3 COMPONENTS WITH THE SCREW IDENTIFIED AS THE MOST PROBLEMATIC. THE ERROR WAS NOTICED AFTER DELIVERY, PROMPTING EXAMINATION OF ALL STORED ARTICLES, WHICH EXHIBITED THE SAME ISSUE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772117 ↗
• MalfunctionDec 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INSTRUMENT COULD NOT CONNECT TOGETHER. THE COMPLAINED ARTICLE CONSISTS OF 3 COMPONENTS WITH THE SCREW IDENTIFIED AS THE MOST PROBLEMATIC. THE ERROR WAS NOTICED AFTER DELIVERY, PROMPTING EXAMINATION OF ALL STORED ARTICLES, WHICH EXHIBITED THE SAME ISSUE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772115 ↗
• MalfunctionJan 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THAT THE CUSTOMER REPORTED POST OP- NO REMOVAL OF THE INSTRUMENT POSSIBLE AFTER INITIAL APPLICATION. NO PATIENT HARM, NO SURGERY DELAY. THIS REPORT IS FOR ONE (1) PRIME ROD HOLDER PUSHROD. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129991 ↗
• MalfunctionDec 20, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT A CHIPPED ROD HOLDER PUSH ROD WAS DISCOVERED. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) PRIME ROD HOLDER PUSHROD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017902 ↗
• MalfunctionOct 4, 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 AFTER ATTACHING AND TIGHTENING THE ROD, THE INSTRUMENTS SEIZED TOGETHER. THE ROD COULD ONLY BE LOOSENED WITH THE APPLICATION OF FORCE. THE INSTRUMENTS REMAINED SEIZED. THERE WAS NO SURGERY DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. THE SURGERY WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY UNKNOWN) . THIS REPORT IS FOR ONE (1) PRIME ROD HOLDER PUSHROD. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10624693 ↗
• MalfunctionSep 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES SIX (6) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10566753 ↗