UNK - Screws: Expedium
Received Jul 27, 2026 · Event occurred Jun 14, 2026
Report 1526439-2026-01082 · MDR key 50005646
Device
Generic name
Thoracolumbosacral Pedicle Screw System
Manufacturer
Depuy Spine IncCatalog number
UNK - Screws: Expedium
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Fistula
Narrative
Description of Event or Problem
It was reported that the patient presented with a fistula and which required an assessment of the previously implanted hardware. An Expedium Verse system was dispatched to the facility; however, during the procedure, it was discovered that the implanted hardware was actually an Expedium Adult transpedicular system. The affected screws were subsequently removed using the facility's own instruments. The patient has been referred for infection management, and the procedure for re-fixation is pending rescheduling.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (b)(4). This report is being submitted pursuant to the provisions of 21 CFR, Part 803 (and/or Part 4, as applicable). This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by DePuy Synthes, or its employees that the report constitutes an admission that the product, DePuy Synthes, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. H11. Additional Manufacturer Narrative: D4: UDI: As the catalog/model number was not provided, the (01)GTIN is not available.