VIPER PRIMERecalls & reported problems across all models
Medos International Sàrl · 60 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 609
- Deaths reported
- 0
- Injuries reported
- 117
- Recalls
- 0
We found 60 models of VIPER PRIME by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 609 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2017 and Sep 22, 2026 — classified as 117 injuries, 492 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (228 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported VIPER PRIME problems
Device problems
- Device-Device Incompatibility228
- Break129
- Calibration Problem67
- Material Twisted/Bent51
- Device Slipped33
- Migration33
- Adverse Event Without Identified Device or Use Problem22
- Compatibility Problem20
Patient problems
- No Clinical Signs, Symptoms or Conditions384
- No Consequences Or Impact To Patient62
- Insufficient Information42
- Foreign Body In Patient22
- No Code Available20
- Pain19
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available16
- No Patient Involvement14
VIPER PRIME models
60 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VIPER PRIME 286750100ORTHOPEDIC MANUAL SURGICAL INSTRUMENT83 reports
- VIPER PRIME 286750070SCREWDRIVER56 reports
- VIPER PRIME 286750031Thoracolumbosacral pedicle screw system49 reports
- VIPER PRIME 286750062ORTHOPEDIC MANUAL SURGICAL INSTRUMENT23 reports
- VIPER PRIME 286750036Orthopedic stereotaxic instrument22 reports
- VIPER PRIME 286750131NOrthopedic stereotaxic instrument21 reports
- VIPER PRIME 286750035Orthopedic stereotaxic instrument19 reports
- VIPER PRIME 286750083INSTRUMENT, COMPRESSION18 reports
- VIPER PRIME 186770445SAPPLIANCE, FIXATION, SPINAL INTERLAMINAL18 reports
- VIPER PRIME 286750032Orthopedic stereotaxic instrument17 reports
- VIPER PRIME 286750041Orthopedic stereotaxic instrument17 reports
- VIPER PRIME 286750061ORTHOPEDIC MANUAL SURGICAL INSTRUMENT17 reports
- VIPER PRIME 186770345SAppliance, fixation, spinal intervertebral body17 reports
- VIPER PRIME 286750200SThoracolumbosacral pedicle screw system15 reports
- VIPER PRIME 186760450SAppliance, fixation, spinal intervertebral body14 reports
- VIPER PRIME 186770340SThoracolumbosacral pedicle screw system12 reports
- VIPER PRIME 286750033Orthopedic stereotaxic instrument11 reports
- VIPER PRIME 286750063ORTHOPEDIC MANUAL SURGICAL INSTRUMENT11 reports
- VIPER PRIME 186770445Thoracolumbosacral pedicle screw system11 reports
- VIPER PRIME 186760445SAPPLIANCE, FIXATION, SPINAL INTERLAMINAL11 reports
- VIPER PRIME 286750034Thoracolumbosacral pedicle screw system10 reports
- VIPER PRIME 186770450SAPPLIANCE, FIXATION, SPINAL INTERLAMINAL10 reports
- VIPER PRIME 186760440SAppliance, fixation, spinal intervertebral body9 reports
- VIPER PRIME 186760445APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY8 reports
- VIPER PRIME 186770440SAPPLIANCE, FIXATION, SPINAL INTERLAMINAL8 reports
- VIPER PRIME 286750020ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- VIPER PRIME 186750445SThoracolumbosacral pedicle screw system7 reports
- VIPER PRIME 186760450APPLIANCE, FIXATION, SPINAL INTERLAMINAL6 reports
- VIPER PRIME 186770335SAPPLIANCE, FIXATION, SPINAL INTERLAMINAL6 reports
- VIPER PRIME 286750010ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- VIPER PRIME 186760240Orthosis, spondylolisthesis spinal fixation5 reports
- VIPER PRIME 286750042Orthopedic stereotaxic instrument4 reports
- VIPER PRIME 286750082INSTRUMENT, COMPRESSION4 reports
- VIPER PRIME 186770240APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- VIPER PRIME 186770245Thoracolumbosacral pedicle screw system4 reports
- VIPER PRIME 186770450APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- VIPER PRIME 186745445SAppliance, fixation, spinal intervertebral body4 reports
- VIPER PRIME 186750430SAPPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- VIPER PRIME 286750210SOrthopedic stereotaxic instrument3 reports
- VIPER PRIME 286750150ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- VIPER PRIME 186770350SAppliance, fixation, spinal intervertebral body3 reports
- VIPER PRIME 286750133NOrthopedic stereotaxic instrument2 reports
- VIPER PRIME 186750445APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- VIPER PRIME 186760440Thoracolumbosacral pedicle screw system2 reports
- VIPER PRIME 186770255Thoracolumbosacral pedicle screw system2 reports
- VIPER PRIME 186745440SAppliance, fixation, spinal intervertebral body2 reports
- VIPER PRIME 186750435SAPPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- VIPER PRIME 186750440SAppliance, fixation, spinal intervertebral body2 reports
- VIPER PRIME 186770435SAPPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- VIPER PRIME 186770455SThoracolumbosacral pedicle screw system2 reports
- VIPER PRIME 3010-19-010Orthopedic stereotaxic instrument2 reports
- VIPER PRIME 286750110ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- VIPER PRIME 186750250Orthosis, spondylolisthesis spinal fixation1 report
- VIPER PRIME 186750440APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- VIPER PRIME 186760245Thoracolumbosacral pedicle screw system1 report
- VIPER PRIME 186770340APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- VIPER PRIME 186770440Thoracolumbosacral pedicle screw system1 report
- VIPER PRIME 186775240Orthosis, spondylolisthesis spinal fixation1 report
- VIPER PRIME 186750450SAPPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VIPER PRIME 186770330SAPPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
Recent VIPER PRIME adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Calibration Problem; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857332 ↗MalfunctionSep 10, 2026Compatibility Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717467 ↗MalfunctionSep 10, 2026Compatibility Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717457 ↗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 ↗MalfunctionJun 17, 2026Detachment of Device or Device Component
IT WAS REPORTED DURING A PROCEDURE ON AN UNKNOWN DATE, THE SCREW WAS ATTACHED TO THE SCREWDRIVER BUT THEN FELL OFF AND BECAME UNCLEAN. THE SCREW DID NOT ATTACH TO THE SCREWDRIVER EASIER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25532545 ↗MalfunctionJun 10, 2026Mechanical Problem
IT WAS REPORTED THAT DURING THE SURGERY, SURGEON COULD NOT TIGHTEN THE ZIPFIX. ANOTHER NINE DEVICES WERE USED TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY REPORTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456054 ↗MalfunctionJun 10, 2026Mechanical Problem
IT WAS REPORTED THAT DURING THE SURGERY, SURGEON COULD NOT TIGHTEN THE ZIPFIX. ANOTHER NINE DEVICES WERE USED TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY REPORTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456033 ↗MalfunctionJun 10, 2026Mechanical Problem
IT WAS REPORTED THAT DURING THE SURGERY, SURGEON COULD NOT TIGHTEN THE ZIPFIX. ANOTHER NINE DEVICES WERE USED TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY REPORTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25455708 ↗MalfunctionJun 10, 2026Mechanical Problem
IT WAS REPORTED THAT DURING THE SURGERY, SURGEON COULD NOT TIGHTEN THE ZIPFIX. ANOTHER NINE DEVICES WERE USED TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY REPORTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25455703 ↗MalfunctionJun 8, 2026Material Integrity Problem
IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR SPINAL FUSION (L2-L5) ON (B)(6) 2026. AFTER L2-L5 3-SEGMENT LIF (NON-SYNTHES), PPS FIXATION OF L2-L5 IN THE PRONE POSITION, CEMENT INJECTION WAS PLANNED CRANIOCAUDALLY. PROCEDURE USED VIPERPRIME SCREW, VIPERPRIME FENESTRATED SCREW, CEMENT INJECTION: L2: 1CC/R: 1.2CC, L5: 1CC. A METALLIC SOUND, DIFFERENT FROM THE USUAL, RANG OUT RIGHT BEFORE CUTTING THE TORQUE WHEN FIXING THE SET SCREW AND FINAL FIXING WAS PERFORMED AFTER SCREWING, CEMENT INJECTION, COMPRESSION, RODDING. THE TIP OF THE SET SCREWDRIVER BROKE, AND IT REMAINED IN THE BODY. IT WAS NOT REMOVED BY THE SURGEON¿S DECISION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES SURGICAL DELAY. THE PATIENT'S CONDITION AFTER SURGERY WAS NOT CONFIRMED. THE PATIENT HAS METAL ALLERGY, AND THE SALES REP HAS CHECKED THE SET SCREW DRIVER¿S MATERIAL AND SHARED INFORMATION WITH NURSES AND DOCTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25430840 ↗MalfunctionJun 8, 2026Break
IT WAS REPORTED THAT THE DEVICES HAD BROKEN TIPS. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428141 ↗MalfunctionJun 8, 2026Break
IT WAS REPORTED THAT THE DEVICES HAD BROKEN TIPS. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428100 ↗MalfunctionMay 11, 2026Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE, THE HANDLE WAS BENT. IT WAS NOT POSSIBLE TO PLACE AT SET SCREW FOR PLACEMENT OR FINAL TIGHTENING ON THE TIP OF THE HANDLE. ANOTHER INSTRUMENT WAS USED. SURGERY WAS PERFORMED AS PLANNED. NO CONSEQUENCE FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25142676 ↗MalfunctionMay 7, 2026Break; Entrapment of Device
IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR SPINAL FUSION (L2-L5) ON (B)(6) 2026. AFTER L2-L5 3-SEGMENT LIF (NON-SYNTHES), PPS FIXATION OF L2-L5 IN THE PRONE POSITION, CEMENT INJECTION WAS PLANNED CRANIOCAUDALLY. PROCEDURE USED VIPERPRIME SCREW, VIPERPRIME FENESTRATED SCREW, CEMENT INJECTION: L2: 1CC/R: 1.2CC, L5: 1CC. A METALLIC SOUND, DIFFERENT FROM THE USUAL, RANG OUT RIGHT BEFORE CUTTING THE TORQUE WHEN FIXING THE SET SCREW AND FINAL FIXING WAS PERFORMED AFTER SCREWING, CEMENT INJECTION, COMPRESSION, RODDING. THE TIP OF THE SET SCREWDRIVER BROKE, AND IT REMAINED IN THE BODY. IT WAS NOT REMOVED BY THE SURGEON¿S DECISION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES SURGICAL DELAY. THE PATIENT'S CONDITION AFTER SURGERY WAS NOT CONFIRMED. THE PATIENT HAS METAL ALLERGY, AND THE SALES REP HAS CHECKED THE SET SCREW DRIVER¿S MATERIAL AND SHARED INFORMATION WITH NURSES AND DOCTORS.
Patient problems: Foreign Body In Patient
MAUDE report 25116321 ↗MalfunctionMay 7, 2026Break; Entrapment of Device
IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR SPINAL FUSION (L2-L5) ON (B)(6) 2026. AFTER L2-L5 3-SEGMENT LIF (NON-SYNTHES), PPS FIXATION OF L2-L5 IN THE PRONE POSITION, CEMENT INJECTION WAS PLANNED CRANIOCAUDALLY. PROCEDURE USED VIPERPRIME SCREW, VIPERPRIME FENESTRATED SCREW, CEMENT INJECTION: L2: 1CC/R: 1.2CC, L5: 1CC. A METALLIC SOUND, DIFFERENT FROM THE USUAL, RANG OUT RIGHT BEFORE CUTTING THE TORQUE WHEN FIXING THE SET SCREW AND FINAL FIXING WAS PERFORMED AFTER SCREWING, CEMENT INJECTION, COMPRESSION, RODDING. THE TIP OF THE SET SCREWDRIVER BROKE, AND IT REMAINED IN THE BODY. IT WAS NOT REMOVED BY THE SURGEON¿S DECISION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES SURGICAL DELAY. THE PATIENT'S CONDITION AFTER SURGERY WAS NOT CONFIRMED. THE PATIENT HAS METAL ALLERGY, AND THE SALES REP HAS CHECKED THE SET SCREW DRIVER¿S MATERIAL AND SHARED INFORMATION WITH NURSES AND DOCTORS.
Patient problems: Foreign Body In Patient
MAUDE report 25116320 ↗
Other Medos International Sàrl products
- TRUESPAN ORTHOCORD6 models · 4,109 reports
- FMS39 models · 3,588 reports
- EXPEDIUM291 models · 3,312 reports
- EXPEDIUM VERSE90 models · 2,686 reports
- EXPRESSEW6 models · 2,459 reports
- OMNISPAN ORTHOCORD3 models · 1,581 reports
- HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
- PROWLER SELECT9 models · 1,066 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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