Malibu 12-6545Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10889981001155), received between Sep 12, 2019 and Mar 16, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 reports).

11 other recalls cover devices cleared under the same FDA submission (K051942); they may or may not involve this specific model.

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

Recent adverse event reports

The 4 most recent of 4 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 9835491 ↗
• 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 9835423 ↗
• MalfunctionMar 14, 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. PLEASE SEE ADDITIONAL INFORMATION CONCERNING RECALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9832612 ↗
• MalfunctionSep 12, 2019Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2019 A PATIENT CONTACTED THE MANUFACTURER ALLEGING A POST-OPERATIVE SCREW FAILURE WITH A POSTERIOR FIXATION SYSTEM. INFORMATION PROVIDED FROM THE PATIENT DETERMINED THE INDEX SURGERY DATE ((B)(6) 2010) AND MODEL NUMBER (12-6545 MALIBU POLYAXIAL SCREW). IT IS UNKNOWN HOW THE SCREW FAILURE WAS DISCOVERED. IT IS UNKNOWN IF A REVISION IS SCHEDULED. NO RADIOGRAPHS OR CASE SHEET IS AVAILABLE. PATIENT WAS ADVISED TO CONTACT A PHYSICIAN.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9014504 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051942. One submission often covers many models, so check the product and lot details in each record.

• Z-0938-2014 · Jan 22, 2014 · Terminated
  Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The M
• Z-1920-2009 · Mar 4, 2009 · Terminated
  Malibu Polyaxial Screw, 6.5 x 40mm Part Number 12-6540 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to pro
• Z-1926-2009 · Mar 4, 2009 · Terminated
  Malibu Polyaxial Reduction Screw, 6.5 x 45mm Part Number 13-6545 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System
• Z-1919-2009 · Mar 4, 2009 · Terminated
  Malibu Polyaxial Screw, 6.5 x 35mm Part Number 12-6535 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to pr
• Z-1923-2009 · Mar 4, 2009 · Terminated
  Malibu Polyaxial Screw, 7.5 x 35mm Part Number 12-7535 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to pro
• Z-1921-2009 · Mar 4, 2009 · Terminated
  Malibu Polyaxial Screw, 6.5 x 45mm Part Number 12-6545 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to pro
• Z-1927-2009 · Mar 4, 2009 · Terminated
  Malibu Polyaxial Reduction Screw, 6.5 x 50mm Part Number 13-6550 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System
• Z-1922-2009 · Mar 4, 2009 · Terminated
  Malibu Polyaxial Screw, 6.5 x 50mm Part Number 12-6550 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to pro
• Z-1925-2009 · Mar 4, 2009 · Terminated
  Malibu Polyaxial Reduction Screw, 6.5 x 40mm Part Number 13-6540 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System
• Z-1924-2009 · Mar 4, 2009 · Terminated
  Malibu Polyaxial Screw, 7.5 x 70mm Part Number 12-7570 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to pro
• Z-1918-2009 · Mar 4, 2009 · Terminated
  Malibu Polyaxial Screw, 4.5 x 30mm Part Number 12-4530 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to pr