CapSure® Spine System 11-3182Recalls & reported problems
Spine Wave, Inc. · Rod Hex End Straight Ti 5.5mm X 400mm · Class 2 · Implant
Data updated Oct 16, 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 10840642104288), received between Nov 13, 2018 and Nov 13, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Slipped” (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.
Most reported problems
Device problems
- Device Slipped1
- Fracture1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2018Fracture; Device Slipped
IT HAS BEEN REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2016 DUE TO PSEUDARTHROSIS AT THE L5-S1 LEVEL AND HARDWARE FAILURE AT THE L5-S1 LEVEL (ANOTHER MANUFACTURER'S PRODUCT). DURING THIS PROCEDURE, ALL OF THE OTHER MANUFACTURER'S PRODUCT WAS REMOVED FROM ALL AFFECTED LEVELS - T9 THROUGH THE ILIAC CREST - AND REPLACED WITH THE CAPSURE PS SYSTEM. SUBSEQUENTLY, IN (B)(6) 2018, THE PATIENT REPORTED FEELING AN "AUDIBLE POP". REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 DUE TO PSEUDARTHROSIS AND HARDWARE FAILURE. DURING THIS PROCEDURE IT WAS NOTED THAT THE ROD WAS FRACTURED ON THE RIGHT SIDE OF THE CONSTRUCT BETWEEN THE L3 AND L4 LEVELS; MULTIPLE SET SCREWS WERE FOUND LOOSE. THE SURGEON REMOVED AND REPLACED THE FRACTURED ROD AND LOOSE HARDWARE. NO COMPLICATIONS WERE NOTED DURING THIS PROCEDURE.
Patient problems: No Code Available
MAUDE report 8066863 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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