Malibu 76-0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10889981079291), received between Aug 4, 2016 and Sep 10, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2018Mechanical Problem; Mechanical Problem

  ON (B)(6) 2017, PATIENT UNDERWENT SPINAL DEFORMITY SCOLIOSIS SURGERY CONSISTING OF POSTERIOR PEDICLE FIXATION BONE SCREWS; LEVELS OF FIXATION ARE UNKNOWN. THE INITIAL SURGERY WAS COMPLETED WITHOUT COMPLICATION. FIRST POST-OPERATIVE FOLLOW UP IT WAS OBSERVED THE LOCKING CAPS WERE DISENGAGED. NO RADIOGRAPHS PROVIDED FOR REVIEW. REVISION SURGERY WAS PREFORMED (B)(6) 2018 TO REPLACE THREE LOCKING CAPS. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION.

  Patient problems: No Information

  MAUDE report 7862825 ↗
• MalfunctionSep 10, 2018Mechanical Problem; Mechanical Problem

  IN (B)(6) 2017, PATIENT UNDERWENT SPINAL DEFORMITY SCOLIOSIS SURGERY CONSISTING OF POSTERIOR PEDICLE FIXATION BONE SCREWS; LEVELS OF FIXATION ARE UNKNOWN. THE INITIAL SURGERY WAS COMPLETED WITHOUT COMPLICATION. FIRST POST-OPERATIVE FOLLOW UP IT WAS OBSERVED THE LOCKING CAPS WERE DISENGAGED. RADIOGRAPH PROVIDED CONFIRMING DISENGAGED CAP. REVISION SURGERY WAS PREFORMED (B)(6) 2018 TO REPLACE ONE LOCKING CAP. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION.

  Patient problems: No Information

  MAUDE report 7862336 ↗
• MalfunctionJun 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  DEFORMITY CORRECTION SURGERY WAS PERFORMED ON AN ADOLESCENT FEMALE ((B)(6) YRS.) WITH A POSTERIOR FIXATION FROM T2 - L4 (PSO AT L2) ON (B)(6) 2017. DURING A ROUTINE FOLLOW UP RADIOGRAPH NOTED L3 & L4 LOCKING CAPS WERE LOOSE AND L3 RIGHT SCREW HAD SHIFTED, ALLOWING ROD TO SLIP FROM ALIGNMENT. PATIENT WAS ASYMPTOMATIC. REVISION SURGERY WAS PLANNED FOR (B)(6) 2018 TO PERFORM A ROD CUT (USING IMPLANTED ROD) AND DOMINO CONNECTOR TO COMPLETE.

  Patient problems: Failure of Implant

  MAUDE report 7608554 ↗
• MalfunctionDec 28, 2017Disassembly; Mechanical Problem; Disassembly; Mechanical Problem

  DURING ROUTINE FOLLOW UP OF A SPINAL DEROTATION AND FUSION, PATIENT WAS NOTED TO HAVE AN AXIAL SLIP ON A POSTERIOR CONSTRUCT. LOCKING CAP WAS LOOSE ON THE ROD. REVISION SURGERY IS PLANNED, BUT HAS NOT OCCURRED. PATIENT STATUS IS UNKNOWN. INDEX SURGERY DATE IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 7153464 ↗
• MalfunctionSep 15, 2017Disassembly; Mechanical Problem; Disassembly; Mechanical Problem

  PATIENT HAD BILATERAL POSTERIOR CONSTRUCT FROM T4-L3. THE PATIENT HAD A CHANGE TO POSTURE SUGGESTING A CHANGE IN THE CONSTRUCT. FOLLOW UP APPOINTMENT DETERMINED THERE WAS A AXIAL SLIP ON THE CAUDAL END AT L3. REVISION OCCURRED ON (B)(6) 2017 TO REPLACE THE LOOSE LOCK SCREWS AND SECURE THE CONSTRUCT. INDEX SURGERY DATE UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 6869804 ↗
• MalfunctionAug 4, 2016Disassembly; Mechanical Problem; Disassembly; Mechanical Problem

  PATIENT'S INITIAL POSTERIOR LUMBAR FIXATION SURGERY REPORTEDLY OCCURRED APPROXIMATELY 3 MONTHS AGO (EXACT DATE UNKNOWN.) DURING FOLLOW UP VISIT IT WAS DISCOVERED THAT THE BOTH S1 ILIAC LOCKING SCREWS HAD LOOSENED, AND THE ROD DISASSOCIATED FROM THE ILIAC BONE SCREWS. LENGTH OF CONSTRUCT AND LEVELS TREATED ARE UNKNOWN. PATIENT HISTORY IS UNKNOWN. PATIENT STATUS IS UNKNOWN. SURGEON IS MONITORING AND IS PLANNING A REVISION SURGERY, DATE IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 5848866 ↗

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-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-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-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-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-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-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-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-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