VIPER 175710130Recalls & reported problems
Medos International Sàrl · VIPER F2 FACET FIXATION SYSTEM WASHER 13mm · Class U · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034034751), received between Sep 12, 2018 and Sep 12, 2018 — classified as 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.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2018Break; Break
DEPUY SYNTHES RECEIVED A VOICE MAIL FROM (B)(6), SALES REP, REPORTING THAT DURING A LAMINECTOMY PROCEDURE ON (B)(6) 2018 METAL PIECES OF DEVICE 175710535 AND 175710130 BROKE OFF IN THE PATIENT. HE STATED THAT THIS CAME FROM THE TEETH. THE SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT WAS NOT HARMED. THE SURGEON WAS UPSET THAT THIS OCCURRED. SYNTHES CREATED (B)(4) FOR THE DOCUMENTATION OF THIS COMPLAINT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7870037 ↗
Other SYSTEM, FACET SCREW SPINAL DEVICE devices
- ZYFUSE 147.541SGlobus Medical, Inc. · SYSTEM, FACET SCREW SPINAL DEVICE1 report
- Zyfix Spinal Facet Screw System X076-0020Xtant Medical Holdings, Inc. · SYSTEM, FACET SCREW SPINAL DEVICE1 report
- 4.5mm BONE-LOK PLS Implant LSW-45-4555Interventional Spine, Inc · System, Facet Screw Spinal Device1 report
- CORRIDOR 148.540Globus Medical, Inc. · SYSTEM, FACET SCREW SPINAL DEVICE1 report
- VIPER 175710535Medos International Sàrl · SYSTEM, FACET SCREW SPINAL DEVICE1 report
- ION 55 Facet Implant - Sterile TI-K-55Surgentec, LLC · System, Facet Screw Spinal Device1 report
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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