ReLine 16387555PRecalls & reported problems
Nuvasive, Inc. · RELINE MAS-T Screw+LS, 7.5x55mm Cann · Class 2 · Implant
All models of ReLine (129)
Data updated Oct 16, 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 00887517043931), received between Jun 15, 2026 and Jun 15, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Disconnection1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2026Disconnection
IT WAS REPORTED THAT DURING A POSTOP ROUTINE PATIENT CONTROL, A FAILURE OF THE INITIAL CONSTRUCT WAS IDENTIFIED BY THE SURGEONS OA. ANDREAS FLOSSMANN AND OA. WACLAV BRUNNER-URBANSKI. RIGHT SIDED ROAD HAS COMPLETELY DISLOCATED FROM THE TULIPS AFTER 3 MONTHS, BUT SET SCREWS ARE STILL IN PLACE. NO INTEROPERATIVE PROBLEMS HAVE BEEN OCCURRING ON THE PRIMARY TREATMENT. NO ISSUES HAVE BEEN DOCUMENTED. PILE DRIVER HAS BEEN USED FOR ALL MONO SCREWS TO SECURE A PROPER FIT OF THE ROD/SCREW/SET SCREW CONSTRUCT.
Patient problems: Failure of Implant
MAUDE report 25510710 ↗
Other bone cement, posterior screw augmentation devices
- VIPER 186727645Medos International Sàrl · bone cement, posterior screw augmentation3 deaths27 reports
- VIPER 186727745Medos International Sàrl · bone cement, posterior screw augmentation23 reports
- EXPEDIUM VERSE 199723645Medos International Sàrl · bone cement, posterior screw augmentation21 reports
- EXPEDIUM VERSE 199723745Medos International Sàrl · bone cement, posterior screw augmentation13 reports
- VIPER 186727640Medos International Sàrl · bone cement, posterior screw augmentation2 deaths11 reports
- VIPER 186727850Medos International Sàrl · bone cement, posterior screw augmentation9 reports
- EXPEDIUM VERSE 199723435Medos International Sàrl · bone cement, posterior screw augmentation6 reports
- EXPEDIUM VERSE 199723655Medos International Sàrl · bone cement, posterior screw augmentation4 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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