FDA Adverse Event Injury Summary report: N

BONE SCREW INTERNAL SPINAL FIX.

MDR report key: 21435185 · Received February 21, 2025

Report

Report Number
MW5166683
Event Type
Injury
Date Received
February 21, 2025
Date of Event
January 23, 2025
Report Date
February 18, 2025
Manufacturer
HYHTE HOLDINGS INC., DBA ASTURA MEDICAL
Product Code
OVE
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

ANTERIOR CERVICAL FUSION C4-5, C5-6 ON (B)(6) 2025 WHO HAS HAD TREMENDOUS POSTOPERATIVE SURGICAL PAIN GOING DOWN HER LEFT ARMS WITH FEELINGS OF WEAKNESS AND DISCOMFORT. IMAGING WITH MRI AND CT WERE DONE ON (B)(6) 2025 AND IT SHOWS HER SOME TYPE OF METALLIC ARTIFACT PUSHING INTO HER SPINAL CORD AREA. WE OBTAINED AN EMERGENT MRI WHICH SHOWED A [INVALID]A HAIR-LIKE THICK [INVALID]THAT WAS CURLING PUSHING ONTO THE SPINAL CORD AT C6-7 AND GOING STRAIGHT FORWARD AT C4-C5. A CT SCAN OF THE CERVICAL SPINE WAS DONE TO CONFIRM THAT WE WERE DEALING WITH MOST LIKELY A METALLIC COIL COMING FROM THE SCREWS. EMERGENCY SURGERY ON (B)(6) 2025- PER SURGEON: THE 2 LOCKING SCREWS WERE REMOVED, AND THE CAGE WAS TAKEN OUT WITH A KOCHER. THE MICROSCOPE WAS BROUGHT IN AND IMMEDIATELY WE COULD SEE A METAL [INVALID]COMING FROM UNDER THE BODY OF C6 STICKING UP. NO ACTIVE CSF LEAKAGE WAS SEEN. I CAREFULLY CREATE A PLANE BETWEEN THE METAL COIL AND THE VERTEBRAL BODY AND THEN I WAS ABLE TO RETRIEVE THE PIECE IN TOTAL WITH A PITUITARY. THE LENGTH WAS APPROXIMATELY A CM AND A HALF. THE AFFECTED SCREWS WERE COMPARED TO NORMAL SCREWS AND WE COULD CLEARLY SEE THAT THEY WERE STRIPPED AND HAD A REDUCED DIAMETER. IN OTHER WORDS, A COIL OF METAL HAD COME OFF DURING INSERTION OF THE SCREWS AND MANEUVERED ITS WAY TOWARDS THE SPINAL CORD AT BOTH LEVELS. THIS IS CLEARLY A MALFUNCTION OF THE DEVICE USED. CT IMPRESSION: RECENT ANTERIOR DISCECTOMY AND FUSION C4-5 AND C5-6 WITH INTERBODY DISC GRAFTS AND OBLIQUE ENDPLATE SCREWS. THERE ARE 2 LINEAR WIRES EXTENDING FROM THE DORSAL PROSTHESES INTO THE VENTRAL EPIDURAL SPACE AS DISCUSSED ABOVE, CAUSING MASS EFFECT UPON THE LEFT VENTRAL THECAL SAC BOTH AT THE SUPERIOR ENDPLATE OF C5, AND THE INFERIOR ENDPLATE OF C6. THESE FINDINGS APPEAR TO ACCOUNT FOR THE APPEARANCE ON RECENT MRI. NO HARDWARE LOOSENING OR FAILURE. ADDITIONAL DEGENERATIVE FINDINGS AS DISCUSSED. MR/MR CERVICAL SPINE WO CON IMPRESSION: STATUS POST INTERVERTEBRAL BODY DISC SPACER PLACEMENT AT C4-5 AND C5-6. QUESTIONABLE 7 MM SPINAL ARACHNOID CYST, LEFT VENTRAL ASPECT CENTRAL SPINAL CANAL AT C6-7 RESULTING IN VENTRAL DEFORMITY OF THE SPINAL CORD WITHOUT CORD EDEMA AND OR MYELOPATHY. CONSIDER IV CONTRAST ENHANCED MRI CERVICAL SPINE. SPONDYLITIC CENTRAL SPINAL CANAL STENOSIS AND LIKELY CORD COMPRESSION AT C4-5 WITHOUT CORD EDEMA AND OR MYELOPATHY. UNCLEAR IF PRODUCT IS STILL AVAILABLE OR IF REPORTED TO MANUFACTURER YET (WORKING ON THIS). NO PRIOR EVENTS NOTED IN MAUDE WITH THIS PRODUCT OVER LAST YEAR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1636975 BONE SCREW INTERNAL SPINAL FIX. INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL OVE HYHTE HOLDINGS INC., DBA ASTURA MEDICAL

Patients

Seq Age Sex Outcome Treatment
1 66 YR Female Required Intervention| O