NA 446.611Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587051932), received between Nov 19, 2025 and Jan 21, 2026 — classified as 2 injuries.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Device Slipped

  LITIGATION RECORD AD (b)(6) 2026UPDATED EVENT DESCRIPTION:IT WAS REPORTED THAT ON OR ABOUT (b)(6) 2002, PATIENT UNDERWENT CRANIAL SURGERY FOR THE TREATMENT OF MENINGIOMA.ON (b)(6) 2002, PATIENT UNDERWENT A SUBSEQUENT BONE FLAP REPLACEMENT. DURING THE PROCEDURE, SYNTHES 1.5 MM TITANIUM CRANIAL PLATES AND APPROXIMATELY FORTY FIVE (45) TITANIUM SCREWS WERE PERMANENTLY IMPLANTED IN PATIENT'S SKULL.FOLLOWING THE INITIAL IMPLANTATION, PATIENT EXPERIENCED ONGOING COMPLICATIONS RELATED TO THE CRANIAL HARDWARE, INCLUDING HARDWARE PROTRUSION, WOUND BREAKDOWN, AND INFECTION.PATIENT FURTHER EXPERIENCED REPEATED SURGICAL INTERVENTIONS (2008, 2011, 2023, 2025) AND DOCUMENTED "FULLY SHREDDED SCREWS" AND FAILED PLATES.ON (b)(6) 2008, PATIENT UNDERWENT A RIGHT OCCIPITAL/TEMPORAL/SUBOCCIPITAL CRANIOTOMY AND POSTERIOR MASTOIDECTOMY WITH MESH CRANIOPLASTY.PATIENT UNDERWENT A SUBSEQUENT BONE FLAP REPLACEMENT PROCEDUREON (b)(6)2011, PATIENT REQUIRED SURGICAL INTERVENTION FOR REMOVAL OF PROTRUDING TITANIUM MESH FROM THE RIGHT PARIETAL AREA.ON (b)(6) 2011, PATIENT UNDERWENT RADICAL EXCISION OF INFECTED SKIN AND UNDERLYING TITANIUM MESH WITH TOWER ISLAND TRAPEZIUS FLAP RECONSTRUCTION.ON (b)(6) 2023, PATIEN

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24136009 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PRODUCT THAT I'M HAVING ISSUES WITH WAS MEDICAL IMPLANTS. I HAD FOUR REVISION SURGERIES BECAUSE THE TITANIUM SCREWS FELL OUT, MIGRATED, LOOSENED, AND SHREDDED. ALSO, MY LAST SURGERY, IT WAS JUST A WAIT THAT WAS COMING THROUGH MY SKIN.

  Patient problems: Insufficient Information

  MAUDE report 23597947 ↗