VIPER PRIME 286750062Recalls & reported problems
Medos International Sàrl · VIPER PRIME ROD HOLDER SHAFT · Class 1
All models of VIPER PRIME (60)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Medos VIPER PRIME rod holder shaft is an orthopedic surgical instrument used to handle rods during procedures. The 24 reports mainly describe parts not fitting or threading together, holders stuck on rods, and occasional bending during attempts to detach them; there were no deaths or injuries. No recalls name this device, and reports rose to 19 in the past 12 months from 0 in the previous 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705034507682), received between Sep 22, 2020 and Apr 27, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (23 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility23
- Material Twisted/Bent5
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
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 24998260 ↗MalfunctionDec 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THERE WAS SOMETHING WRONG WITH THE THREAD OF THE VIPER PRIME ROD HOLDER SHAFT, THE SHAFT CANNOT BE SCREWED INTO VIPER PRIME ROD HOLDER STEM. THE ISSUE WAS DURING THE LOAN SET INSPECTION. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23840227 ↗MalfunctionDec 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THERE WAS SOMETHING WRONG WITH THE THREAD OF THE VIPER PRIME ROD HOLDER SHAFT, THE SHAFT CANNOT BE SCREWED INTO VIPER PRIME ROD HOLDER STEM. THE ISSUE WAS DURING THE LOAN SET INSPECTION. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23840177 ↗MalfunctionDec 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THERE WAS SOMETHING WRONG WITH THE THREAD OF THE VIPER PRIME ROD HOLDER SHAFT, THE SHAFT CANNOT BE SCREWED INTO VIPER PRIME ROD HOLDER STEM. THE ISSUE WAS DURING THE LOAN SET INSPECTION. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23840165 ↗MalfunctionDec 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THERE WAS SOMETHING WRONG WITH THE THREAD OF THE VIPER PRIME ROD HOLDER SHAFT, THE SHAFT CANNOT BE SCREWED INTO VIPER PRIME ROD HOLDER STEM. THE ISSUE WAS DURING THE LOAN SET INSPECTION. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23840152 ↗MalfunctionDec 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THERE WAS SOMETHING WRONG WITH THE THREAD OF THE VIPER PRIME ROD HOLDER SHAFT, THE SHAFT CANNOT BE SCREWED INTO VIPER PRIME ROD HOLDER STEM. THE ISSUE WAS DURING THE LOAN SET INSPECTION. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23840138 ↗MalfunctionDec 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT DOES NOT SCREW IN ALL THE WAY, EVEN WHEN APPLYING A LITTLE FORCE. THE DEVICE WAS BRAND NEW AND UNUSED, AND LUBRICATING IT DID NOT RESOLVE THE ISSUE. THE EVENT WAS ASSOCIATED WITH NO PATIENT CONSEQUENCES OR CLINICAL SYMPTOMS, AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826785 ↗MalfunctionDec 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT DOES NOT SCREW IN ALL THE WAY, EVEN WHEN APPLYING A LITTLE FORCE. THE DEVICE WAS BRAND NEW AND UNUSED, AND LUBRICATING IT DID NOT RESOLVE THE ISSUE. THE EVENT WAS ASSOCIATED WITH NO PATIENT CONSEQUENCES OR CLINICAL SYMPTOMS, AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826764 ↗MalfunctionDec 15, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT DID NOT SCREW IN ALL THE WAY, EVEN WHEN APPLYING FORCE. THE DEVICE WAS BRAND NEW AND HAD NEVER BEEN USED. LUBRICATION DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23806490 ↗MalfunctionDec 15, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT DID NOT SCREW IN ALL THE WAY, EVEN WHEN APPLYING FORCE. THE DEVICE WAS BRAND NEW AND HAD NEVER BEEN USED. LUBRICATION DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23806473 ↗MalfunctionDec 15, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT DID NOT SCREW IN ALL THE WAY, EVEN WHEN APPLYING FORCE. THE DEVICE WAS BRAND NEW AND HAD NEVER BEEN USED. LUBRICATION DID NOT RESOLVE THE ISSUE. THERE WAS NO DELAY TO THE SURGERY AND THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23805816 ↗MalfunctionDec 15, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT DID NOT SCREW IN ALL THE WAY, EVEN WHEN APPLYING FORCE. THE DEVICE WAS BRAND NEW AND HAD NEVER BEEN USED. LUBRICATION DID NOT RESOLVE THE ISSUE. THERE WAS NO DELAY TO THE SURGERY AND THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23805735 ↗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 23759502 ↗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 23759492 ↗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 23759445 ↗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) & (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 23759431 ↗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) & (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 23759419 ↗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 23759396 ↗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 2 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16129989 ↗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 SHAFT. THIS IS REPORT 2 OF 2 FOR COMPLAINT: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15163101 ↗MalfunctionOct 9, 2020Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (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 COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT INVOLVES ONE (1) VIPER PRIME ROD HOLDER SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 10656415 ↗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 SHAFT. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10624690 ↗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 10566792 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page