VIPER PRIME 186750250Recalls & reported problems
Medos International Sàrl · VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 5 x 50mm · Class 2 · Implant
All models of VIPER PRIME (60)
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 10705034509068), received between Sep 29, 2020 and Sep 29, 2020 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
- No Code Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2020Break; Break
THE PREVIOUS HARDWARE WAS PARTIALLY REMOVED AND NEW HARDWARE WAS INSERTED TO TWO ADDITION LEVELS BILATERALLY. PORTION OF LEFT SIDED SCREWS WERE IMPACTED IN BONE AND COULD NOT BE RETRIEVED. THE BROKEN SCREWS WERE ENCASED IN BONE TOO ANTERIOR IN THE VERTEBRAL BODY; RETRIEVAL WOULD HAVE BEEN DAMAGING TO THE INTEGRITY OF THE ANATOMY. IT WAS ALSO REPORTED THE L4/L5 REGION WAS NOT FUSED AND STILL MOBILE AND THE PATIENT EXPERIENCED A LITTLE PAIN. IT WAS NOTED THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT: (B)(4) CAPTURES THE POST-OPERATIVELY BROKEN SCREWS. RELATED COMPLAINT: (B)(4) CAPTURES THE INTRA-OPERATIVE EVENT OF THE SCREWS IMPACTED IN BONE NOT BEING ABLE TO BE REMOVED.
Patient problems: Failure of Implant; No Code Available; Pain
MAUDE report 10600378 ↗
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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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