MalibuRecalls & reported problems across all models
Seaspine Orthopedics Corporation · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 17 models of Malibu by Seaspine Orthopedics Corporation in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2016 and Sep 18, 2024 — classified as 6 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Malibu problems
Device problems
- Material Integrity Problem15
- Corroded14
- Detachment of Device or Device Component12
- Mechanical Problem9
- Fracture4
- Disassembly3
- Migration3
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant16
- No Known Impact Or Consequence To Patient16
- Patient Problem/Medical Problem6
- No Clinical Signs, Symptoms or Conditions2
- No Information2
- No Consequences Or Impact To Patient1
Malibu models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Malibu 12-0010Orthosis, spondylolisthesis spinal fixation10 reports
- Malibu 76-0010ORTHOSIS, SPINAL PEDICLE FIXATION6 reports
- Malibu 12-6545Orthosis, spondylolisthesis spinal fixation4 reports
- Malibu 12-7545Orthosis, spondylolisthesis spinal fixation2 reports
- Malibu™ 12-1060Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- Malibu™ 12-1070ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- Malibu 91-6117PROBE2 reports
- Malibu 12-0020ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Malibu 12-6550Orthosis, spondylolisthesis spinal fixation1 report
- Malibu 15-7535Orthosis, spondylolisthesis spinal fixation1 report
- Malibu 69-5530ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Malibu 69-5535APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Malibu 69-5540Orthosis, spondylolisthesis spinal fixation1 report
- Malibu™ 12-1040Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Malibu 76-0020Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Malibu 91-2109SCREWDRIVER1 report
- Malibu 91-2111SCREWDRIVER1 report
Recent Malibu adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2024Fracture; Fracture
ON (B)(6) 2023, A 13-YEAR OLD PATIENT UNDERWENT SPINAL SURGERY FOR L5 SPONDYLITIS UTILIZING SEASPINE'S MALIBU DELTA SCREWS. THE LEVELS COVERED DURING SURGERY WERE L4 -S1. SOMETIME IN (B)(6) 2024, THE PATIENT WAS GETTING INTO THEIR BED WHEN THEY FELT SOMETHING MOVE. THE NEXT DAY, THE PATIENT WENT IN TO GET AN X-RAY AND IT WAS DETERMINED THE PATIENT EXPERIENCED A POST-OPERATIVE SCREW FRACTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20248546 ↗InjuryDec 30, 2020Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration
SEASPINE WAS INFORMED ON (B)(6) 2020 THAT A PATIENT WHO PREVIOUSLY UNDERWENT SPINAL SURGERY FROM LEVEL T2-L2 CONSISTING OF SEASPINE'S MALIBU SPINAL SYSTEM REQUIRED REVISION SURGERY AS A RESULT OF A POSTOPERATIVE LOCKING CAP SEPARATION AT THE T12, L1, AND L2 LEVELS.
Patient problems: Failure of Implant
MAUDE report 11098479 ↗MalfunctionNov 26, 2020Fracture; Fracture
ON (B)(6) 2020, THE PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MALIBU PEDICLE SCREW SYSTEM. SEASPINE WAS INFORMED ON 30 OCT 2020 THAT THE IMPLANT SCREWDRIVER BROKE WHILE IMPLANTING A SCREW. THE DRIVER TIP WAS LEFT IN THE SCREW IN-SITU. NO INJURY WAS REPORTED, NOR ANY ADDITIONAL MEDICAL OR SURGICAL TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10909207 ↗MalfunctionSep 24, 2020Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration
ON 1 SEP 2020, SEASPINE WAS MADE AWARE THAT SEVERAL PATIENTS WERE EXPERIENCING LOSS OF REDUCTION/CORRECTION AND PAIN AS A RESULT OF THE DISASSOCIATION OF A MALIBU SPINAL SYSTEM LOCKING CAP.
Patient problems: Failure of Implant
MAUDE report 10581015 ↗MalfunctionSep 24, 2020Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration
ON (B)(6) 2020, SEASPINE WAS MADE AWARE THAT SEVERAL PATIENTS WERE EXPERIENCING LOSS OF REDUCTION/CORRECTION AND PAIN AS A RESULT OF THE DISASSOCIATION OF A MALIBU SPINAL SYSTEM LOCKING CAP.
Patient problems: Failure of Implant
MAUDE report 10580974 ↗InjuryJun 24, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
SEASPINE WAS INFORMED ON (B)(6) 2020 THAT A PATIENT WHO PREVIOUSLY UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S MALIBU SPINAL SYSTEM REQUIRED REVISION SURGERY AS A RESULT OF A POSTOPERATIVE LOCKING CAP SEPARATION AT L5. THE INDEX SURGERY AND DATE OF REVISION IS UNKNOWN. THE SEPARATION WAS DISCOVERED DURING A ROUTINE FOLLOW-UP VIA X-RAY.
Patient problems: Failure of Implant; Patient Problem/Medical Problem
MAUDE report 10190233 ↗MalfunctionMar 16, 2020Corroded; Material Integrity Problem; Corroded; Material Integrity Problem
ON FEBRUARY 18, 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 9837199 ↗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 9837163 ↗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 9837125 ↗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. PLEASE SEE ADDITIONAL INFORMATION CONCERNING RECALL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9837116 ↗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 9837081 ↗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 9835545 ↗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 ↗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 9835497 ↗
Other Seaspine Orthopedics Corporation products
- Mariner15 models · 147 reports · 1 recall
- Daytona Small Stature3 models · 14 reports · 2 recalls
- Fathom3 models · 2 reports · 2 recalls
- NorthStar24 models · 15 reports · 1 recall
- Meridian8 models · 8 reports · 1 recall
- Mariner Deformity3 models · 2 reports · 1 recall
- Virata25 models · 0 reports · 1 recall
- Reef TA2 models · 0 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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