Malibu 69-5530Recalls & reported problems
Seaspine Orthopedics Corporation · UNI-PLANAR DLTA SCREW,5.5 X 30 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981008642), received between Mar 21, 2019 and Mar 21, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
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.
MalfunctionMar 21, 2019Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth
ON (B)(6) 2017, THE PATIENT UNDERWENT POSTERIOR SPINAL FIXATION USING THE DAYTONA PEDICLE SCREW SYSTEM. DURING SUBSEQUENT PATIENT FOLLOW-UP AN X-RAY WAS TAKEN, AND IT WAS OBSERVED THAT A FRACTURE OF THE PEDICLE SCREWS HAD OCCURRED AT T12, TWO YEARS POST-OPERATION. ADDITIONALLY, IT WAS INDICATED THAT PSEUDARTHROSIS WAS VISIBLE FROM THE X-RAY. AT THE TIME OF CONTACT, REVISION SURGERY HAD NOT YET BEEN SCHEDULED, BUT THE SURGEON REPORTED THAT THEY PLANNED TO REVISE. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 8441327 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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