InjuryDZL
BONESCREW,AXS,ST,2.0X8MM,5P
Received Jul 10, 2026 · Event occurred Jun 15, 2026
Report 0008010177-2026-00093 · MDR key 25776149
Device
Generic name
Screw, Fixation, Intraosseous
Manufacturer
Stryker Leibinger FreiburgCatalog number
56-20408
Lot number
UNKNOWN
Product problems
- Fracture
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POSTOPERATIVELY, THE PLATE BECAME LOOSE DUE TO SCREW BACKOUT. DURING REVISION SURGERY, A SHEARED SCREW HEAD WAS IDENTIFIED, REQUIRING REPLACEMENT OF THE PLATE AND SCREWS. THE SURGEON ATTRIBUTED THE FAILURE TO PATIENT BONE QUALITY RATHER THAN A DEVICE RELATED ISSUE.