Malibu 12-0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10889981000738), received between Mar 16, 2018 and Dec 30, 2020 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Corroded” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJun 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2019 A DEFORMITY CORRECTION SURGERY WAS PERFORMED. LEVELS AND PATIENT INFO (AGE, SEX, RACE) ARE UNKNOWN. A ROUTINE FOLLOW-UP X-RAY SHOWED A LOCKING CAP HAD BACKED OUT. ON (B)(6) 2019 A REVISION SURGERY WAS PERFORMED, WHICH CONSISTED OF REPLACING AND SECURING ONE LOCKING CAP. FOLLOW-UP TO REVISION DETERMINED PATIENT IS WITHOUT PAIN AND RECOVERING WELL. SURGEON TO MONITOR PATIENT PROGRESS THROUGH ROUTINE FOLLOW-UPS.

  Patient problems: Failure of Implant

  MAUDE report 8724867 ↗
• MalfunctionMar 16, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  DEFORMITY CORRECTION SURGERY WAS PERFORMED ON A ADOLESCENT FEMALE (AGE UNKNOWN) WITH POSTERIOR FIXATION FROM L4- T11 ON (B)(6) 2017. FIXATION WAS SKIPPED AT LEVELS: LEFT L3, RIGHT L1, AND BOTH RIGHT AND LEFT T12. DURING A ROUTINE FOLLOW UP ON (B)(6) 2018 RADIOGRAPH NOTED RIGHT L4, L3, L2 HAD LOOSE LOCK SCREWS. PATIENT WAS ASYMPTOMATIC. REVISION SURGERY WAS PERFORMED REPLACING TWO BONE SCREWS, AND THREE LOCK SCREWS.

  Patient problems: Failure of Implant

  MAUDE report 7345444 ↗

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-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-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-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-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-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
• 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-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-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-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