VIPER PRIME 186775240Recalls & reported problems
Medos International Sàrl · VIPER PRIME X-TAB POLYAXIAL SCREW 5.5 7.5 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034509679), received between Jul 24, 2020 and Jul 24, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE L4-5 MIS TLIF SURGERY, THE VIPER PRIME SCREW GOT STUCK TO THE GREEN KNOB ON THE VIPER PRIME SCREWDRIVER. IT COULD NOT BE REMOVED. THE SURGEON'S TECHNIQUE DOES NOT USE THE STYLET. HE USES BLUNT K-WIRE. SECOND SCREWDRIVER IN THE SET WAS USED. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN K-WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1)VIPER PRIME X-TAB, 7.5X40MM TI. THIS IS REPORT 02 OF 02 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10323037 ↗
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- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
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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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