VIPER PRIME 286750061Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705034507675), received between Jun 11, 2020 and May 1, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON HAD ISSUES REMOVING BOTH ROD HOLDERS FROM THE RODS DESPITE TRYING TO DETACH PER THE SURGICAL TECHNIQUE. THE SURGEON PERSEVERED IN DETACHING THE ROD HOLDERS FROM THE ROD. THERE WAS NO IMPACT TO PATIENT OR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059059 ↗
• MalfunctionMay 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON HAD ISSUES REMOVING BOTH ROD HOLDERS FROM THE RODS DESPITE TRYING TO DETACH PER THE SURGICAL TECHNIQUE. THE SURGEON PERSEVERED IN DETACHING THE ROD HOLDERS FROM THE ROD. THERE WAS NO IMPACT TO PATIENT OR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059048 ↗
• 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 24998333 ↗
• MalfunctionMar 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE VIPER PRIME ROD HOLDER STEM FELL APART INTRAOPERATIVELY DURING A MINIMALLY INVASIVE DEGENERATIVE PROCEDURE. THE GREEN HANDLE BECAME LOOSE FROM THE METAL SHAFT, RENDERING THE INSTRUMENT UNUSABLE. THE SURGERY WAS COMPLETED WITHOUT DELAY USING ANOTHER INSTRUMENT FROM THE SET, AND THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649212 ↗
• MalfunctionDec 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE INSTRUMENTS COULD NOT CONNECT TOGETHER. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. (B)(4) RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IPS FROM (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759566 ↗
• MalfunctionDec 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE INSTRUMENTS COULD NOT CONNECT TOGETHER. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. (B)(4). RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE ADDITIONAL IPS FROM (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759560 ↗
• MalfunctionNov 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. KINDLY CONFIRM EXACT ALLEGATION AGAINST PRODUCT DETAILS OF "PEN". - THE PEN IS AN COMPONENT OF THE ITEM AND WAS SENT IN FOR INVESTIGATION TO COMPLETE THE "ITEM". THE DEFECT ITEM IS THE SCREW AS MENTIONED. B. INITIALLY TWO HANDLE WAS REPORTED LATER, KINDLY CONFIRM ALLEGATION AGAINST ANOTHER TWO PRODUCTS. - ALL OTHER HANDLES HAVE THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466503 ↗
• MalfunctionNov 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. KINDLY CONFIRM EXACT ALLEGATION AGAINST PRODUCT DETAILS OF "PEN". - THE PEN IS AN COMPONENT OF THE ITEM AND WAS SENT IN FOR INVESTIGATION TO COMPLETE THE "ITEM". THE DEFECT ITEM IS THE SCREW AS MENTIONED. B. INITIALLY TWO HANDLE WAS REPORTED LATER, KINDLY CONFIRM ALLEGATION AGAINST ANOTHER TWO PRODUCTS. - ALL OTHER HANDLES HAVE THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466501 ↗
• MalfunctionOct 31, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION FOR OVF ON (B)(6) 2025. BEFORE THE SURGERY, THE NURSE INFORMED THE SALES REP THAT ONE OF THE ROD HOLDER HAD FAILED TO ASSEMBLE. THE SALES REP ASKED THE NURSE TO ASSEMBLE IT ON THE SPOT, BUT WHEN SHE TRIED TO SCREW IN THE ROD HOLDER SHAFT, WHICH IS NORMALLY ASSEMBLED, IT GOT STUCK HALFWAY THROUGH AND WAS UNABLE TO ASSEMBLE. SINCE THERE WERE TWO OF THE ROD HOLDERS, THE NURSE COMBINED IT WITH THE OTHER ROD HOLDER STEM AND IT ASSEMBLED WITHOUT ANY PROBLEMS. IN THE END, THE SURGERY WAS PERFORMED USING ONLY ONE ROD HOLDER THAT WAS ABLE TO BE ASSEMBLED, BUT THE SURGEON COMMENTED THAT THIS TIME, HE WANTED TO USE TWO ROD HOLDERS, ONE ON EACH SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SALES REP VISUALLY INSPECTED THE PRODUCT AND TRIED TO ASSEMBLE IT AGAIN HIMSELF, BUT IT STILL GOT STUCK HALFWAY THROUGH AND WAS UNABLE TO ASSEMBLE. THE SALES REP SUSPECT THAT THE THREADS AT THE BACK OF THE PRODUCT WHERE IT FITS WITH THE ROD HOLDER SHAFT MAY HAVE BEEN DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434849 ↗
• MalfunctionNov 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ROD COULDN'T BE TIGHTLY FIT INTO THE ROD HOLDER. THEREFORE IT WASN'T TIGHT ENOUGH SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20601220 ↗
• MalfunctionSep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT AS REPORTED THE VIPER PRIME ROD STEM DISASSEMBLED BETWEEN THE HANDLE AND THE TIP. A NEW DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170882 ↗
• 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 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129995 ↗
• MalfunctionAug 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PPS IN THE THORACIC SPINE FOR TREATING TRAUMA ON (B)(6) 2022. THE SURGEON HAD DIFFICULTY IN ATTACHING A ROD (UNK) TO THE COUNTER DEVICES (THE ROD HOLDER SHAFT AND THE ROD HOLDER STEM).THE SURGERY WAS SUCCESSFULLY COMPLETE. PATIENT IS IN STABLE CONDITION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER PRIME ROD HOLDER STEM. THIS IS REPORT 1 OF 2 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163099 ↗
• MalfunctionOct 16, 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, WHEN THE SURGEON FINISHED PLACING THE ROD, AND TRIED TO REMOVE THE ROD HOLDER, THE ROD HOLDER WOULD NOT DISENGAGE FROM THE ROD. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10691031 ↗
• 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) VIPER PRIME ROD HOLDER STEM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10624687 ↗
• 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 10566724 ↗
• MalfunctionJun 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR AN UNKNOWN SURGERY ON (B)(6) 2020. DURING THE SURGERY IT WAS DISCOVERED THAT THE ROD HOLDER STEM UNCOUPLED AND MAKING DIFFICULT ITS EXTRACTION. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY WITH OR WITHOUT DELAY. THERE WERE NO CONSEQUENCES OF PATIENT REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10144036 ↗