VIPERRecalls & reported problems across all models
Depuy Spine, LLC · 60 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,148
- Deaths reported
- 2
- Injuries reported
- 135
- Recalls
- 0
We found 60 models of VIPER by Depuy Spine, LLC in the FDA's device registry (GUDID). Together they are named in 1,148 adverse event reports in the FDA's MAUDE database, received between Oct 27, 2014 and Sep 25, 2026 — classified as 2 deaths, 135 injuries, 1,011 malfunctions.
The most frequently reported specific device problem is “Break” (510 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 problems
Device problems
- Break510
- Material Twisted/Bent296
- Device-Device Incompatibility160
- Calibration Problem62
- Entrapment of Device42
- Adverse Event Without Identified Device or Use Problem30
- Mechanical Problem29
- Material Deformation24
Patient problems
- No Clinical Signs, Symptoms or Conditions703
- No Consequences Or Impact To Patient179
- Foreign Body In Patient73
- Insufficient Information72
- No Code Available36
- No Known Impact Or Consequence To Patient30
- Not Applicable24
- No Patient Involvement19
VIPER models
60 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VIPER 286745550DRIVER, PROSTHESIS263 reports
- VIPER 279734000SCREWDRIVER241 reports
- VIPER 286735400DRIVER, PROSTHESIS106 reports
- VIPER 286745500ORTHOPEDIC MANUAL SURGICAL INSTRUMENT94 reports
- VIPER 286725020DRIVER, PROSTHESIS48 reports
- VIPER 286710490ORTHOPEDIC MANUAL SURGICAL INSTRUMENT44 reports
- VIPER 286740020EXTRACTOR44 reports
- VIPER 286725200ORTHOPEDIC MANUAL SURGICAL INSTRUMENT39 reports
- VIPER 186789480APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY19 reports
- VIPER 286735200ORTHOPEDIC MANUAL SURGICAL INSTRUMENT19 reports
- VIPER 286705220ORTHOPEDIC MANUAL SURGICAL INSTRUMENT16 reports
- VIPER 286725225ORTHOPEDIC MANUAL SURGICAL INSTRUMENT15 reports
- VIPER 286735730ORTHOPEDIC MANUAL SURGICAL INSTRUMENT15 reports
- VIPER 286715300ORTHOPEDIC MANUAL SURGICAL INSTRUMENT12 reports
- VIPER 286715500TAP, BONE12 reports
- VIPER 286715600TAP, BONE12 reports
- VIPER 286735100ORTHOPEDIC MANUAL SURGICAL INSTRUMENT11 reports
- VIPER 186788045Orthosis, spondylolisthesis spinal fixation10 reports
- VIPER 286735725ORTHOPEDIC MANUAL SURGICAL INSTRUMENT10 reports
- VIPER 186789200Pedicle screw spinal system, adolescent idiopathic scoliosis8 reports
- VIPER 286760010DRIVER, PROSTHESIS8 reports
- VIPER 186789300Orthosis, spondylolisthesis spinal fixation2 deaths7 reports
- VIPER 286705200ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- VIPER 186788070APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY6 reports
- VIPER 286735430DRIVER, PROSTHESIS6 reports
- VIPER 286705230ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- VIPER 286710116PROBE5 reports
- VIPER 286735350DRIVER, PROSTHESIS5 reports
- VIPER 286735750ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- VIPER 186788035Pedicle screw spinal system, adolescent idiopathic scoliosis4 reports
- VIPER 186788085APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- 4 reports
- VIPER 286740000FORCEPS4 reports
- VIPER 186788080Pedicle screw spinal system, adolescent idiopathic scoliosis3 reports
- VIPER 186788090APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- VIPER 286725300ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- VIPER 186788040APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- VIPER 186788060ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- VIPER 186788075APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- VIPER 186789150APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- VIPER 286710500TAP, BONE2 reports
- VIPER 286715350ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- VIPER 286760210ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- VIPER 186788050Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- VIPER 186788055Orthosis, spondylolisthesis spinal fixation1 report
- VIPER 186788065ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- VIPER 186788120Orthosis, spondylolisthesis spinal fixation1 report
- VIPER 186789160ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- VIPER 186789180Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- VIPER 186789400APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VIPER 286705210ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- VIPER 286710200PROBE1 report
- VIPER 286715450TAP, BONE1 report
- VIPER 286715700TAP, BONE1 report
- VIPER 286725010DRIVER, PROSTHESIS1 report
- VIPER 286725410CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- VIPER 286735050GAUGE, DEPTH1 report
- VIPER 286735600CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- VIPER 286735735ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- VIPER 286760350CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY1 report
Recent VIPER adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Twisted/Bent
It was reported that the end off the screwdriver is stripped. There was no surgical delay or patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900350 ↗MalfunctionSep 25, 2026Material Twisted/Bent
It was reported that the end off the screwdriver is stripped. There was no surgical delay or patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900346 ↗MalfunctionSep 22, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859426 ↗MalfunctionSep 22, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859417 ↗MalfunctionAug 27, 2026Material Twisted/Bent
It was reported during the procedure the final tighter stripped which meant the final torquing of the construct could not be completed with the instrument. A second instrument in the kit was available. No patient impact and only a small 1-minute delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479015 ↗MalfunctionAug 27, 2026Material Twisted/Bent
It was reported that these final tighteners were missing from the set. The staff advised me they were removed as they had also stripped and were not working.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50477088 ↗MalfunctionAug 27, 2026Material Twisted/Bent
It was reported that these final tighteners were missing from the set. The staff advised me they were removed as they had also stripped and were not working.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50477060 ↗MalfunctionAug 12, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227988 ↗MalfunctionJul 27, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022477 ↗MalfunctionJul 27, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022475 ↗MalfunctionJul 10, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25782193 ↗MalfunctionJul 9, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25765501 ↗MalfunctionJun 29, 2026Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE TIP OF DRIVE SHAFT WORN AND WAS NOT ENGAGING SET SCREW CORRECTLY. THERE WAS NO SURGICAL DELAY AND NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659363 ↗MalfunctionJun 26, 2026Break
IT WAS REPORTED THE TORQUE WRENCH BROKE WHEN WE TRIED TO APPLY THE FINAL TIGHTENING. NO PATIENT HARM. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637797 ↗MalfunctionJun 18, 2026Break
IT WAS REPORTED TWO INSTRUMENTS BROKE DURING A PROCEDURE. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A FIVE MINUTE DELAY AND NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25551626 ↗
Other Depuy Spine, LLC products
All Depuy Spine, LLC devices →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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