InjuryGXZ
RLSND131-2.5
Received Mar 27, 2023 · Event occurred Feb 28, 2023
Report 1067162-2023-00001 · MDR key 16619859
Device
Generic name
Subdermal Needle Electrode
Manufacturer
Rhythmlink International, LlcModel number
RLSND131-2.5Catalog number
RLSND131-2.5
Lot number
PM00024421
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
DURING A TRANSFORAMINAL INTERBODY FUSION THE DEVICE WAS USED AS AN ULNAR STIMULATING ELECTRODE AT THE WRIST. UPON REMOVAL, THE NEEDLE BROKE AND A PIECE OF THE NEEDLE REMAINED IN THE PATIENT REQUIRING A SMALL INCISION TO REMOVE. THE PART NUMBER WAS IDENTIFIED AS (B)(4), LOT NUMBER PM00024421.