MAUDE Adverse Event Report: SPINE WAVE, INC. CAPSURE POLYAXIAL SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number LOG84801

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 10/05/2020

Event Type  Injury  

Event Description

Lumbar spinal fusion pedicle screws used in the fusion subsequently have broken.Noticed new pain and the feeling of something hard pressing on my low back (b)(6) 2023.Appointment with the (b)(6) neurosurgery dept in (b)(6) 2023 showed broken screws.Surgeon, (b)(6) surgeon, (b)(6) was hostile and rude when i saw him on (b)(6) and asked him about the manufacturer of the screws.He rudely asked if i wanted revision surgery or not then left the exam room.No discussion, no reassurance, etc.I then requested my medical record from (b)(6) hospital but still have not received them.After calling and emailing medical records twice, i received a letter from medical records last week telling me a doctor was reviewing my record and that i will receive my record by (b)(6) 2023 in (b)(6) of 2021, my adult son (b)(6), age 48, had a cervical spinal fusion done by (b)(6) as well.He found out in (b)(6) 2022 that the screws used in his procedure had broken and that he will need revision surgery.(b)(6) was told that the revision surgery will be more complicated than the first.The revision will require incisions in both the front and back of his upper spine/neck.The first surgery was done from the front of (b)(6) neck.(b)(6) is a type i diabetic.Both (b)(6) and i trusted dr (b)(6) so initially assumed the failure of the screws were likely due to a manufacturer failure and that covid supply chain shortages may have played a role.However, now that (b)(6) is stalling in providing medical records and dr (b)(6) hostile behavior, we can't help but wonder if he as well as an equipment defect has led to our failed fusions.Can you please advise if you have received or are receiving other inquiries regarding titanium pedicle screws failures during the time period 2020 and beyond, and especially with procedures done at (b)(6) hospital.Note, both (b)(6) and i followed post-op instructions, completed pt, and were told that the fusions looked good at all the follow up visits within the year of the surgeries.So, how or why did the screws break and the fusions fail? i, at age 77, and (b)(6) as a diabetic, are concerned about having to undergo revision spinal surgery.Can you please look into our initial surgeries and how and why the titanium screws used have broken? reference report #mw5122862.

Event Description

Additional information received from reporter on 20-sep-2023 for mw5122861.Updating device, procode and manufacturer information.I have since learned that spine wave, inc.Was the maker of the screws used in my surgery.According to my operative record, screws and their numbers are listed as capsure ps3 log84801 polyaxial screw, number used 6, spine wave, inc 111 implanted; capsure locking screw log84801 locking screw number used 8, spine wave, inc 111 implanted; capsure locking screw log84801 polyaxial screw number used 2, spine wave, inc 111 implanted.There are other items listed such as rods and chips.Reference reports: mw5122862, mw5145963.

• Brand Name: CAPSURE POLYAXIAL SCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): SPINE WAVE, INC.
• MDR Report Key: 17498269
• MDR Text Key: 320895511
• Report Number: MW5122861
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: LOG84801
• Device Lot Number: 111
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/20/2023
• Patient Sequence Number: 1
• Treatment: "RODS AND CHIPS"; AMOLODIPINE; ARMOUR THYROID; BENADRYL
• Patient Outcome(s): Disability; Hospitalization; Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White