Malibu™ 12-1060Recalls & reported problems
Seaspine Orthopedics Corporation · PRECONTOURED ROD, 5.5 x 60mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889981029975), received between Mar 16, 2020 and Mar 16, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Corroded” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Corroded2
- Material Integrity Problem2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2020Corroded; Material Integrity Problem; Corroded; Material Integrity Problem
ON (B)(6) 2020 SEASPINE WAS INFORMED OF A MALIBU SPINAL SYSTEM REMOVAL SURGERY. THE INDEX SURGERY WAS (B)(6) 2008. THE PRIMARY REASON FOR THE REMOVAL WAS PATHOLOGY AT AN ADJACENT LEVEL AND NOT DUE TO FAILURE OF THE IMPLANT. DURING THE REMOVAL, CORROSION WAS DISCOVERED WHERE THE ROD AND SCREW INTERFACED. THE DISTRIBUTOR EXPRESSED THE SURGEON'S CONCERN REGARDING THE MALIBU SCREW RECALL THAT TOOK PLACE SHORTLY AFTER THE INDEX SURGERY. THE REFERENCED RECALL WAS DUE TO THE MANUFACTURER USING THE WRONG METAL INSIDE THE TULIP HEAD OF THE SCREW.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9835527 ↗MalfunctionMar 16, 2020Corroded; Material Integrity Problem; Corroded; Material Integrity Problem
ON (B)(6) 2020 SEASPINE WAS INFORMED OF A MALIBU SPINAL SYSTEM REMOVAL SURGERY. THE INDEX SURGERY WAS (B)(6) 2008. THE PRIMARY REASON FOR THE REMOVAL WAS PATHOLOGY AT AN ADJACENT LEVEL AND NOT DUE TO FAILURE OF THE IMPLANT. DURING THE REMOVAL, CORROSION WAS DISCOVERED WHERE THE ROD AND SCREW INTERFACED. THE DISTRIBUTOR EXPRESSED THE SURGEON'S CONCERN REGARDING THE MALIBU SCREW RECALL THAT TOOK PLACE SHORTLY AFTER THE INDEX SURGERY. THE REFERENCED RECALL WAS DUE TO THE MANUFACTURER USING THE WRONG METAL INSIDE THE TULIP HEAD OF THE SCREW.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9835516 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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