NA 421.502Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587050362), received between Aug 12, 2020 and May 18, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THIS CASE IS FROM THE HEALTH AUTHORITY. THE PATIENT HAD SURGERY WITH PLATES AND SCREWS ONE AND A HALF YEARS AGO. HE RECOVERED WELL AND WAS DISCHARGED HALF A MONTH LATER. HOWEVER, 10 MONTHS LATER, THE PATIENT REPORTED THAT THE HEAD PROSTHETIC MATERIAL WAS EXPOSED, THE SCALP WAS DEFECTIVE, AND A SMALL AMOUNT OF YELLOWISH FLUID WAS SPILLED ON THE EXPOSED AREA. A SECOND SURGERY WAS PERFORMED AND THE PATIENT WAS DISCHARGED 10 DAYS LATER WITH GOOD RECOVERY. TWO MONTHS LATER, THE PATIENT HAD SWELLING AND PAIN IN THE RIGHT TEMPORAL REGION FOR ANOTHER WEEK, AND EXAMINATION REVEALED EFFUSION AND BLOOD. A THIRD SURGICAL PROCEDURE WAS THEN PERFORMED AND THE SCALP WAS INCISED AND APPROXIMATELY 5 CM IN LENGTH WITH A LARGE GUSH OF FLUID. IT WAS CONSIDERED THAT THE INFECTION COULD NOT BE CONTROLLED, SO THE PLATE WAS REMOVED AND THE PATIENT RECOVERED WELL. A FOURTH REPAIR SURGERY IS SCHEDULED THIS MONTH.

  Patient problems: Fluid Discharge; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 25209602 ↗
• MalfunctionJul 28, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT DURING THE SURGERY, THE SCREW WAS BROKEN,AND ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) CRANIAL-PL 1.6 STRAIG W/CENT-SPACE 2HO T THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415788 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ACOUSTIC NEUROMA RESECTION RETROSIGMOID PROCEDURE. THE PATIENT WAS IMPLANTED WITH AN UNKNOWN BONE PLATES AND PUTTY CEMENT. POSTOPERATIVELY, THE PATIENT WAS ADMITTED TO HOSPITAL FOR ILLICIT POLYPHARMACY THAT WAS RESOLVED. REPORTS OCCASIONAL EAR PAIN. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI LOW PROFILE NEURO STRAIGHT PLATE 2 HOLES. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10398899 ↗