VIPERRecalls & reported problems across all models
Medos International Sàrl · 121 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 863
- Deaths reported
- 11
- Injuries reported
- 515
- Recalls
- 0
We found 121 models of VIPER by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 863 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2017 and Sep 29, 2026 — classified as 11 deaths, 515 injuries, 337 malfunctions.
The most frequently reported specific device problem is “Break” (294 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
- Break294
- Adverse Event Without Identified Device or Use Problem177
- Device Slipped83
- Loose or Intermittent Connection75
- Migration54
- Device-Device Incompatibility43
- Entrapment of Device36
- Material Twisted/Bent35
Patient problems
- No Clinical Signs, Symptoms or Conditions190
- No Code Available100
- No Consequences Or Impact To Patient99
- Insufficient Information73
- Osteolysis73
- Pain64
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available55
- Failure of Implant53
VIPER models
121 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- VIPER 186715000APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- VIPER 286720000DRIVER, PROSTHESIS54 reports
- VIPER 186731745ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- VIPER 186727750ORTHOSIS, SPINAL PEDICLE FIXATION31 reports
- VIPER 186727645bone cement, posterior screw augmentation3 deaths27 reports
- VIPER 186727745bone cement, posterior screw augmentation23 reports
- VIPER 186731645Orthosis, spondylolisthesis spinal fixation23 reports
- VIPER 186731740Orthosis, spondylolisthesis spinal fixation22 reports
- VIPER 186727650ORTHOSIS, SPINAL PEDICLE FIXATION2 deaths18 reports
- VIPER 186715640APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY16 reports
- VIPER 179704880Orthosis, spondylolisthesis spinal fixation16 reports
- VIPER 186731845APPLIANCE, FIXATION, SPINAL INTERLAMINAL14 reports
- VIPER 186731750APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY13 reports
- VIPER 186770145APPLIANCE, FIXATION, SPINAL INTERLAMINAL13 reports
- VIPER 186731640Orthosis, spinal pedicle fixation, for degenerative disc disease12 reports
- VIPER 186727640bone cement, posterior screw augmentation2 deaths11 reports
- VIPER 186770045APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY10 reports
- VIPER 279704400DRIVER, PROSTHESIS10 reports
- VIPER 279704401SCREWDRIVER10 reports
- VIPER 286705320ORTHOPEDIC MANUAL SURGICAL INSTRUMENT10 reports
- VIPER 186727740ORTHOSIS, SPINAL PEDICLE FIXATION9 reports
- VIPER 186727850bone cement, posterior screw augmentation9 reports
- VIPER 186770140APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY9 reports
- VIPER 186715645APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY8 reports
- VIPER 186717645Pedicle screw spinal system, adolescent idiopathic scoliosis8 reports
- VIPER 186720535APPLIANCE, FIXATION, SPINAL INTERLAMINAL8 reports
- VIPER 186731650APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY8 reports
- VIPER 186715650APPLIANCE, FIXATION, SPINAL INTERLAMINAL7 reports
- VIPER 179704990Orthosis, spinal pedicle fixation, for degenerative disc disease7 reports
- VIPER 186727840ORTHOSIS, SPINAL PEDICLE FIXATION7 reports
- VIPER 186727845ORTHOSIS, SPINAL PEDICLE FIXATION7 reports
- VIPER 186770150ORTHOSIS, SPINAL PEDICLE FIXATION7 reports
- VIPER 186715745Orthosis, spondylolisthesis spinal fixation6 reports
- VIPER 186715850Orthosis, spinal pedicle fixation, for degenerative disc disease6 reports
- VIPER 186717640Orthosis, spondylolisthesis spinal fixation6 reports
- VIPER 279726400ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- VIPER 186788040SOrthosis, spondylolisthesis spinal fixation6 reports
- VIPER 179704870APPLIANCE, FIXATION, SPINAL INTERLAMINAL6 reports
- VIPER 186727755ORTHOSIS, SPINAL PEDICLE FIXATION6 reports
- VIPER 279718100SCREWDRIVER6 reports
- VIPER 186731850ORTHOSIS, SPINAL PEDICLE FIXATION6 reports
- VIPER 286715500NOrthopedic stereotaxic instrument6 reports
- VIPER 186760140APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY6 reports
- VIPER 279726508DISPENSER, CEMENT1 death5 reports
- VIPER 179704890ORTHOSIS, SPINAL PEDICLE FIXATION5 reports
- VIPER 179704970APPLIANCE, FIXATION, SPINAL INTERLAMINAL5 reports
- VIPER 186727545ORTHOSIS, SPINAL PEDICLE FIXATION5 reports
- VIPER 186731435ORTHOSIS, SPINAL PEDICLE FIXATION5 reports
- VIPER 186760145Orthosis, spondylolisthesis spinal fixation5 reports
- VIPER 186715750ORTHOSIS, SPINAL PEDICLE FIXATION4 reports
- VIPER 186770040Orthosis, spondylolisthesis spinal fixation4 reports
- VIPER 179704980Orthosis, spondylolisthesis spinal fixation4 reports
- VIPER 179706880ORTHOSIS, SPINAL PEDICLE FIXATION4 reports
- VIPER 186727080ORTHOSIS, SPINAL PEDICLE FIXATION4 reports
- VIPER 186727855ORTHOSIS, SPINAL PEDICLE FIXATION4 reports
- VIPER 186727980ORTHOSIS, SPINAL PEDICLE FIXATION4 reports
- VIPER 186731840Orthosis, spondylolisthesis spinal fixation4 reports
- VIPER 186760040ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- VIPER 186760045Orthosis, spinal pedicle fixation, for degenerative disc disease3 reports
- VIPER 179706890APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- VIPER 186727540ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- VIPER 186727655ORTHOSIS, SPINAL PEDICLE FIXATION2 deaths3 reports
- VIPER 186731525APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- VIPER 186731530Orthosis, spondylolisthesis spinal fixation3 reports
- VIPER 186717550APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- VIPER 186717650Orthosis, spondylolisthesis spinal fixation2 reports
- VIPER 186717740APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- VIPER 186717745Pedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- VIPER 186760050Orthosis, spondylolisthesis spinal fixation2 reports
- VIPER 279726402DISPENSER, CEMENT2 reports
- VIPER 179706990Orthosis, spondylolisthesis spinal fixation2 reports
- VIPER 186719765ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- VIPER 186727045ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- VIPER 186727535bone cement, posterior screw augmentation2 reports
- VIPER 186727875ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- VIPER 186727880ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- VIPER 186727940ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- VIPER 186727945ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- VIPER 279704055CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY2 reports
- VIPER 186731440ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- VIPER 186731540APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- VIPER 186731545Orthosis, spondylolisthesis spinal fixation2 reports
- VIPER 286715600NOrthopedic stereotaxic instrument2 reports
- VIPER 286705340ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- VIPER 175710130SYSTEM, FACET SCREW SPINAL DEVICE1 report
- VIPER 175710535SYSTEM, FACET SCREW SPINAL DEVICE1 report
- VIPER 186715535Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- VIPER 186715845Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- VIPER 186720530Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- VIPER 286737010ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- VIPER 186788045SOrthosis, spondylolisthesis spinal fixation1 report
- VIPER 186788080SAppliance, fixation, spinal intervertebral body1 report
- VIPER 179706999Orthosis, spondylolisthesis spinal fixation1 report
- VIPER 186719780Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- VIPER 186719865APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- VIPER 186727040ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- VIPER 186727550ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- VIPER 186727555bone cement, posterior screw augmentation1 report
- VIPER 186727630bone cement, posterior screw augmentation1 report
- VIPER 186727765bone cement, posterior screw augmentation1 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 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936669 ↗MalfunctionMay 29, 2026Material Twisted/Bent
IT WAS REPORTED THE DEVICE TIP WAS WORN DOWN. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330796 ↗MalfunctionApr 8, 2026Device-Device Incompatibility
IT WAS REPORTED THAT A SCREW WOULDN´T COME LOOSE FROM THE SCREWDRIVER, RESULTING IN THE NEED TO USE A NEW SCREW AND SCREWDRIVER. THERE WAS A 5 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24819470 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT THERE WAS A BROKEN SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24499641 ↗MalfunctionMar 2, 2026Break
IT WAS REPORTED THAT THIS WAS A SPINAL FUSION(T10-SAI) PERFORMED ON (B)(6) 2026. WHILE INSERTING THE SAI SCREW, THE PATIENT'S BONE WAS TOO HARD, CAUSING THE TIP OF THE SCREWDRIVER TO BREAK OFF APPROXIMATELY 3 MM. THIS WAS DISCOVERED AFTER THE SCREW WAS INSERTED AND REMOVED, AND IT IS UNCLEAR WHEN IT BROKE. THE BROKEN TIP REMAINED INSIDE THE SCREW, BUT IT WAS ABLE TO BE EXTRACTED USING A K-WIRE. A 9 MM X 90 MM SCREW WAS INSERTED, AND THE TAP WAS ADJUSTED FROM 2 MM UNDER TO A SAME TAP, BUT THE SCREW WAS TOO STRONG. THE SURGEON BELIEVED THAT THE PATIENT'S BONE WAS TOO HARD, CAUSING THE BREAK, AND THERE WERE NO PARTICULAR COMPLAINTS ABOUT THE PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24490472 ↗InjuryFeb 26, 2026Break; Entrapment of Device; Device-Device Incompatibility
IT WAS REPORTED THAT THERE WERE TWO BROKEN SCREWS AT THE S1 LOCATION. THE SCREWS FRACTURED JUST BELOW THE CORTICAL THREADS, AND THE REMAINDER OF THE SCREWS HAD TO BE LEFT IN THE BODY IN THE SACRUM. IT IS REPORTED THAT THE BREAKAGE OCCURRED DURING A REVISION PROCEDURE WHEN THE SURGEON ATTEMPTED TO REMOVE THE SCREWS, HOWEVER IT IS ALSO REPORTED THAT IT IS UNCLEAR WHETHER THE FAILURE HAPPENED DURING REMOVAL, IMPLANTATION, OR THE HEALING PROCESS.
Patient problems: Foreign Body In Patient
MAUDE report 24457616 ↗InjuryFeb 26, 2026Break; Entrapment of Device; Device-Device Incompatibility
IT WAS REPORTED THAT THERE WERE TWO BROKEN SCREWS AT THE S1 LOCATION. THE SCREWS FRACTURED JUST BELOW THE CORTICAL THREADS, AND THE REMAINDER OF THE SCREWS HAD TO BE LEFT IN THE BODY IN THE SACRUM. IT IS REPORTED THAT THE BREAKAGE OCCURRED DURING A REVISION PROCEDURE WHEN THE SURGEON ATTEMPTED TO REMOVE THE SCREWS, HOWEVER IT IS ALSO REPORTED THAT IT IS UNCLEAR WHETHER THE FAILURE HAPPENED DURING REMOVAL, IMPLANTATION, OR THE HEALING PROCESS.
Patient problems: Foreign Body In Patient
MAUDE report 24457612 ↗MalfunctionFeb 18, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE VCFFX SCREW COULD NOT BE LOCKED WITH SET SCREW. THERE WAS A THIRTY (30) MINUTE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24379850 ↗InjuryFeb 10, 2026Break; Entrapment of Device
IT WAS REPORTED THAT MIS TI CFX FEN POLY 7X50 AND MIS TI CFX FEN POLY 7X55 WERE INVOLVED IN AN INTRAOPERATIVE EVENT DURING A POSTERIOR SPINAL FUSION PROCEDURE. THE REPORTED FAILURE INVOLVED BOTH SCREWS BREAKING INTO TWO OR MORE PIECES INTRAOPERATIVELY, WITH THE TULIP TORN DOWN AND SCREW SHANKS UNABLE TO BE REMOVED. AS A RESULT, FRAGMENTS REMAINED EMBEDDED WITHIN THE PATIENT, AND THE SURGERY WAS PROLONGED BY 30 MINUTES. THE PROCEDURE WAS ULTIMATELY COMPLETED, BUT ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED DUE TO THE RETAINED SCREW SHAFTS. BOTH DEVICES ARE IDENTIFIED AS IMPLANTS AND HAVE REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 24303378 ↗InjuryJan 6, 2026Device Slipped; Migration
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT CONSEQUENCES OR NOT ? - YES, AS MENTIONED A REVISION SURGERY WAS NEEDED TO INSERT NEW TRIALTIS INNIES.
Patient problems: Insufficient Information
MAUDE report 23979314 ↗InjuryDec 16, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION SURGERY FOLLOWING SCREW BREAKAGE. THREE OUT OF FOUR SHANKS WERE FOUND BROKEN IN SITU. THE PATIENT EXPERIENCED RESIDUAL PAIN AT THE OPERATIVE SITE. IMPLANTS WERE RECOVERED/REMOVED. THERE WAS APPROXIMATELY 10 MINUTES OF SURGICAL DELAY DURING REMOVAL OF BROKEN SCREWS.
Patient problems: Pain
MAUDE report 23823898 ↗InjuryDec 16, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION SURGERY FOLLOWING SCREW BREAKAGE. THREE OUT OF FOUR SHANKS WERE FOUND BROKEN IN SITU. THE PATIENT EXPERIENCED RESIDUAL PAIN AT THE OPERATIVE SITE. IMPLANTS WERE RECOVERED/REMOVED. THERE WAS APPROXIMATELY 10 MINUTES OF SURGICAL DELAY DURING REMOVAL OF BROKEN SCREWS.
Patient problems: Pain
MAUDE report 23823897 ↗InjuryDec 16, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION SURGERY FOLLOWING SCREW BREAKAGE. THREE OUT OF FOUR SHANKS WERE FOUND BROKEN IN SITU. THE PATIENT EXPERIENCED RESIDUAL PAIN AT THE OPERATIVE SITE. IMPLANTS WERE RECOVERED/REMOVED. THERE WAS APPROXIMATELY 10 MINUTES OF SURGICAL DELAY DURING REMOVAL OF BROKEN SCREWS.
Patient problems: Pain
MAUDE report 23823895 ↗MalfunctionNov 11, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE ITEM BROKE OFF INSIDE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23526527 ↗InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT THE REOPERATION ON (B)(6) 2023 WITH L3-S SCREW REMOVAL, L2/3 TLIF (NON-JJ PRODUCT: TRITANIUM), L2-SAI SCREW INSERTION (JJ PRODUCTS: VERSEFS, EXPEDIUM DI, AND EXPEDIUM SAI). ON (B)(6) 2025, A L1/2 TLIF WAS PERFORMED DUE TO ADJACENT SEGMENT DYSFUNCTION. L2 TO SAI WERE LEFT AS IS. VERSEFS (1.8CC CEMENT EACH) WAS USED FOR L1, AND RISE (GLOBUS) WAS USED FOR L1/2. CRANK RODS (NUVASIVE) AND ROD CONNECTORS WERE USED TO CONNECT TO THE EXISTING RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SALES REP RECEIVED A COMPLAINT AFTER A CT SCAN ON (B)(6) 2025, SHOWED BILATERAL BREAKAGE OF THE L1 SCREW IN A PATIENT WHO UNDERWENT L1/2 TLIF (VERSEFS + RISE (GLOBUS). THE SCREW BROKE NEAR THE LATERAL HOLE OF THE SCREW. IT IS CURRENTLY UNDECIDED WHETHER OR NOT TO PERFORM SURGERY ON THIS PATIENT IN THE FUTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT AND (B)(4) REPORTS THE REVISION SURGERY PERFORMED ON (B)(6) 2025 WHILE RELATED (B)(4) REPORTS THE BREAKAGE OF THE SCREW OCCURRED AFTER THE SURGERY PERFORMED ON (B)(6) 2025.
Patient problems: Osteolysis
MAUDE report 23491036 ↗
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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