VIPER PRIME 186745440SRecalls & reported problems
Medos International Sàrl · VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 4.5 x 40mm · Class 2 · Implant
All models of VIPER PRIME (60)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034529837), received between Aug 5, 2025 and Aug 5, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Slipped1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT PATIENT UNDERWENT THE PRIMARY SURGERY (L1/L5) ON AN UNKNOWN DATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, IT WAS CONFIRMED THAT THE L1 SCREW HAD LOOSENED. ON (B)(6) 2025, REVISION SURGERY WAS PERFORMED AND THE L1 SCREW WAS REMOVED. WHEN THE SURGEON REMOVED THE L1 SCREW, IT WAS FOUND TO HAVE BROKEN OFF AT THE TRANSVERSE HOLE. THE SURGEON DETERMINED THAT THERE WAS NO PROBLEM AS PART OF THE SCREW WAS STILL RETAINED IN THE CEMENT AND THEN CONTINUED WITH THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT WAS STABLE.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22719848 ↗InjuryAug 5, 2025Device Slipped; Device Slipped
IT WAS REPORTED THAT PATIENT UNDERWENT THE PRIMARY SURGERY (L1/L5) ON AN UNKNOWN DATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, IT WAS CONFIRMED THAT THE L1 SCREW HAD LOOSENED. ON (B)(6) 2025, REVISION SURGERY WAS PERFORMED AND THE L1 SCREW WAS REMOVED. PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22719786 ↗
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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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