EXCELLA III-D SPINAL DEFORMITY SYSTEM
Received Dec 7, 2022 · Event occurred Oct 8, 2022
Report 3004719693-2022-00002 · MDR key 15933630
Device
Generic name
Thoracolumbosacral Pedicle Screw System
Manufacturer
Innovasis, Inc.Model number
E2002Catalog number
E2002
Lot number
2010
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
13 YR · Unknown
- Pain
- Pain
Narrative
Description of Event or Problem
EVENT OCCURRED IN (B)(4), PERU WHEREIN A PATIENT HAD A SPINAL DEFORMITY CONSTRUCT OF MULTIPLE PEDICLE SCREWS IMPLANTED WITH RODS AND LOCKING CAPS. AT A TWO-WEEK POST-OPERATIVE FOLLOW-UP, THE PATIENT HAD NOTICEABLE DEFORMITY, PAIN AND FUNCTIONAL LIMITATION. IMAGING SHOWED MULTIPLE LOCKING CAPS CAME LOOSE, RELEASING THE RODS FROM THE CONSTRUCT IN THE LUMBOSACRAL AREA. REVISION SURGERY WAS PERFORMED TO REPLACE 8 OF THE ORIGINAL 18 SCREWS AND LOCKING CAPS, WHILE THE REMAINING SCREWS, LOCKING CAPS AND RODS REMAINED.