MAGNUM OM-1503Recalls & reported problems
Smith & Nephew, Inc. · MAGNUM X WITH INDEPENDENT TENSIONIN · Class 2 · Implant
All models of MAGNUM (4)
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 00817470006216), received between Mar 6, 2018 and Mar 6, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Cut In Material” (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
- Cut In Material1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2018Inadequacy of Device Shape and/or Size; Cut In Material
IT WAS REPORTED THAT THE WIRE INSIDE THE MAGNUM X ANCHOR ON THE TENSIONING WHEEL BECAME EXPOSED AFTER SEVERAL TURNS PREVENTING CONTINUED TENSIONING OF THE SUTURE AND THE ANCHOR HAD TO BE ABANDONED. A MAGNUM 2 ANCHOR WAS THEN TRIED, BUT THE LENGTH OF SUTURE AVAILABLE TO LOAD INTO THE ANCHOR WAS LESS THAN REQUIRED SO IT COULD NOT BE PROPERLY TENSIONED VIA THE TENSIONING KNOBS AND THAT ANCHOR WAS ALSO ABANDONED. COMPLAINT 2 OF 2. SEE RELATED (B)(4).
Patient problems: No Information
MAUDE report 7315590 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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