OPTIMESH MESH NEURO 5X17X20 MM
Received Oct 2, 2019 · Event occurred Sep 6, 2019
Report MW5090195 · MDR key 9151077
Device
Product problems
- Migration or Expulsion of Device
Patient
59 YR
- Loss of Range of Motion
- Loss of Range of Motion
Narrative
Description of Event or Problem
ON (B)(6) 2019, THE PT WAS TAKEN TO SURGERY FOR A L3 VERTEBROPLASTY WITH OPTIMESH FOR A L3 COMPRESSION FRACTURE. NO COMPLICATIONS NOTED IMMEDIATELY POST-OPERATIVELY. WHILE IN THE RECOVERY ROOM, THE PT WAS ASSESSED AND FOUND TO BE UNABLE TO MOVE LOWER EXTREMITIES FROM THE KNEE DOWN BILATERALLY. THE SURGEON WAS NOTIFIED, A STAT CT ORDERED AND REVEALED NEAR COMPLETE SPINAL BLOCK EXTENDING FROM L2-L3 AND L3-L4 DISC SPACES SECONDARY TO POSTERIOR EXTRUSION OF RADIOPAQUE. PT WAS EMERGENTLY TAKEN BACK TO SURGERY FOR L2-L3 LAMINECTOMY AND REMOVAL OF THE ANTERIOR MORSELIZED ALLOGRAFT. THE PT WAS TAKEN BACK TO OPERATING ROOM ON (B)(6) 2019 FOR A RE-EXPLORATION OF ANTERIOR EPIDURAL SPACE L2-3 WITH REMOVAL AND ATTEMPTED DECOMPRESSION OF BONE FRAGMENTS. FINDINGS INCLUDED POSTERIOR CORTEX OF L3 RETRO PULSED DIFFICULT TO COMPLETELY REDUCE. NO COMPLICATIONS NOTED. POST OPERATIVELY, THE PT CONTINUED TO HAVE NO MOVEMENT BELOW THE KNEES AND MINIMAL TO SOME SENSATION. PT WAS DISCHARGED TO A REHABILITATION FACILITY FOR CONTINUED REHABILITATION AND TREATMENT. FDA SAFETY REPORT ID# (B)(4).