NA 311.060.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587035840), received between Jul 2, 2019 and Jul 2, 2019 — classified as 2 injuries.

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 18, 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.

• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, A HARDWARE REMOVAL OF RAPID RESORBABLE STRUT PLATE WAS PERFORMED DUE TO INFECTION. THERE WAS AN UNKNOWN ALLEGATION AGAINST THE BATTERY PACK-STERILE FOR BATTERY POWERED DRIVER. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH FEVER AND INFECTION AT THE SURGICAL SITE. THE PARENTS ADMITTED ALLOWING THEIR DOG TO LICK THE WOUND SITE ON BABIES HEAD THAT PROBABLY CAUSED THE INFECTION. INITIALLY, THE PATIENT HAD A SAGITTAL SYNOSTOSIS PROCEDURE ON (B)(6) 2017. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 3 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8755705 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED: IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A SECOND SURGERY WAS PERFORMED DUE TO ALLERGIC REACTION TO THE MATERIAL UNDER THE SURGICAL SITE THAT CAUSED INFLAMMATION AND SKIN BREAKDOWN. ITEMS WERE NOT REMOVED OUT OF PATIENTS HEAD BECAUSE THEY ARE RESORBABLE AND DISSOLVE. PATIENT OPEN WOUND HAD TO BE CLEANED AND CARED FOR AND REQUIRED MORE VISITS TO THE SURGEON FOR WOUND HEALING.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Skin Irritation

  MAUDE report 8754025 ↗