VIPER 179706999Recalls & reported problems
Medos International Sàrl · VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 5.5 9 x 100mm · Class 2 · Implant
All models of VIPER (121)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034266602), received between Aug 15, 2018 and Aug 15, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Loose or Intermittent Connection1
Patient problems
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DR. (B)(6) WAS REVISING A 9X100MM FULLY THREADED ILIAC SCREW ON (B)(6) 2018. THE IMPLANT WAS LOOSE WHICH REQUIRED IT TO BE REPLACED. DR. (B)(6) SUCCESSFULLY REMOVED A 9X100MM FULLY THREADED SAI SCREW (1797-06-999) ON THE RIGHT. HE THEN PROCEEDED TO USE A 10MM SAI TAP AND TAPPED THE FULL LENGTH OF 100MM IN THE SAME SCREW HOLE WHERE HE REMOVED THE 9X100MM SCREW. HE THEN PLACED THE NEW 10X100MM SCREW. AT 80MM HE BEGAN TO SEE INCREASED RESISTANCE. HE THEN TOOK A T-HANDLE AND ATTACHED IT TO THE SAI SCREWDRIVER. UPON 5MM OF ADDITIONAL INSERTION, THE TIP OF THE SCREWDRIVER BROKE (15MM OF SCREW THREADS EXPOSED). HE TRIED TO REMOVE THE SCREW BY ¿HELICOPTERING¿ THE SCREW OUT USING A CUSTOM DEVICE. HE WAS UNABLE TO REMOVE THE SCREW. HE DECIDED TO WAIT TILL FRIDAY, (B)(6) 2018 TO REMOVE THE SCREW AND REPLACE IT. THE (B)(6) 2018 REVISION WAS ALREADY SCHEDULED FOR IMPLANTING RODS AND NEW EXPEDIUM INNER SCREWS. PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION: ADDITIONAL ANESTHESIA INCURRED IN ATTEMPT TO REMOVE THE SCREW (FROM THE BROKEN SCREWDRIVER, 15 MINUTES. ACTION TAKEN FOR PROCEDURE:REVISION (B)(6) 2018. SURGERY WAS ALREADY PLANNED FOR PUTTING NEW RODS AND SET
Patient problems: Not Applicable
MAUDE report 7784211 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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