Malibu 69-5535Recalls & reported problems
Seaspine Orthopedics Corporation · UNI-PLANAR DLTA SCREW,5.5 X 35 · Class 2 · Implant
All models of Malibu (17)
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 10889981008659), received between Feb 12, 2020 and Feb 12, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem1
Patient problems
- Failure of Implant1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2020Mechanical Problem; Mechanical Problem
PATIENT UNDERWENT SPINAL SURGERY USING THE MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM. PATIENT HAD A PSEUDOARTHROSIS AT THE BOTTOM (L4/5) OF A LONG SCOLI CONSTRUCT. FUSION DID NOT OCCUR AND TWO OF THE SCREWS FAILED AND BROKE POST-OPERATIVELY. INDEX SURGERY DATE IS UNKNOWN. A REVISION SURGERY TOOK PLACE ON (B)(6) 2020, WHICH CONSISTED OF THE REMOVAL OF BI-LATERAL BROKEN SCREWS AT THE BOTTOM OF THE EXISTING SCOLI CONSTRUCT (T12). A PORTION OF THE SCREW SHAFTS WERE LEFT IN THE PEDICLE AS THE FRACTURE OCCURRED BELOW THE BONEY SURFACE. BILATERAL SCREWS WERE PLACED AT L1 / L2 / L3 (6.5 AND 7.5MM X45MM SCREWS). BI-LATERAL MARINER OUTRIGGER Z-RODS + BILATERAL {(1) OPEN/CLOSED 4-HOLE & (1) CLOSED/CLOSED 4-HOLE LATERAL CONNECTORS} WERE ALSO PLACED ON EACH SIDE. THE REVISION SURGERY WAS SUCCESSFUL AND THE PATIENT IS HEALING WELL, WITH NO FURTHER PLANS TO REVISE.
Patient problems: Failure of Implant; Patient Problem/Medical Problem
MAUDE report 9701438 ↗
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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