Cannulated Compression Headless Screw 04.333.765Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00819917025675), received between Oct 18, 2024 and Oct 21, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. 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.

• MalfunctionOct 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ADVERSE EVENT FROM THE CLINICAL STUDY: AT 9-MONTHS POST-OPERATIVE IMAGING DEMONSTRATED SCREW LOOSE, RADIOLUCENCY; THE SUBJECT WAS ORDERED A BONE GROWTH STIMULATOR AND TOE-OFF BRACE. AT 11-MONTHS POST-OPERATIVE SUBJECT CONTINUED TO HAVE PAIN WITH AMBULATION AND PLANNED TO CONTINUE TO USE BONE GROWTH STIMULATOR AND SIMULTANEOUSLY SCHEDULE SURGERY TO HAVE HARDWARE REMOVED IF NO IMPROVEMENT IS SEEN WITH BONE GROWTH STIMULATOR; IMAGING DEMONSTRATED THAT THE RADIOLUCENCY REMAINED VISIBLE HOWEVER NO NEW SIGNS OF LOOSENING. AT 12-MONTHS POST-OPERATIVE SUBJECT CONTINUED TO USE BONE GROWTH STIMULATOR WITH NO SIGNS OF INCREASED HEALING; IMAGING SHOWS RADIOLUCENCY REMAINED PRESENT. AT 13.5-MONTHS POST-OPERATIVE SUBJECT UNDERWENT HARDWARE REMOVAL SURGERY DUE TO THE NONUNION. ALL HARDWARE WAS REMOVED DURING THE PROCEDURE AND WAS REPLACED WITH A DIFFERENT BRAND'S SYSTEM. SUBJECT WAS TERMINATED FROM THE STUDY UPON REMOVAL OF HEADLESS SCREWS.

  Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture; Radiolucent Lines

  MAUDE report 20500212 ↗
• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FROM CLINICAL INVESTIGATION: AT 19-MONTHS POST-OPERATIVE THE SUBJECT SLIPPED IN THE SHOWER AND PRESENTED TO THE CLINIC WITH A PROBABLE ANTERIOR TALOFIBULAR LIGAMENT SPRAIN WITH QUESTIONABLE SYMPTOMATIC NONUNION OF THE SUBTALAR JOINT. THE SUBJECT WAS PLACED BACK IN A FRACTURE BOOT DURING THE VISIT. AT 23.5 MONTHS POST-OPERATIVE A CT SCAN WAS OBTAINED WHERE NONUNION WAS CONFIRMED. THE SUBJECT HAD THE DEVICES REMOVED 23.5 MONTHS POST-OPERATIVE AND REPLACED WITH OTHER HARDWARE. SUBJECT WAS TERMINATED FROM THE STUDY AFTER HARDWARE REMOVAL.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20486422 ↗