Malibu 15-7535Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981003487), received between Sep 18, 2024 and Sep 18, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 1 most recent of 1 reports, 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 ↗

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-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-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-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-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-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-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-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-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-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