MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER AVAFLEX BALLOON SYSTEM - 11G; CEMENT, BONE, VERTEBROPLASTY

Model Number 031-115-000

Patient Problems Nerve Damage (1979); Pain (1994); Anxiety (2328); Depression (2361); Sleep Dysfunction (2517); Foreign Body In Patient (2687)

Event Date 12/02/2021

Event Type  Injury  

Event Description

On december 2, 2021 i was admitted to (b)(6) hospital, for what was to be a routine kyphoplasty surgical procedure.Typically these procedures are performed in the pain management doctor's office.However, my pain management doctor/surgeon, dr.(b)(6), wanted to perform the procedure at the hospital.The medical equipment / products used for this procedure were provided by the sales representative, (b)(4), with stryker corporation, llc.(aka: stryker spine and stryker international), further identified on line as: afb1115avaflex balloon 11g 15mm, which includes the trocar instrument used during my surgery.This surgery was for a fracture at t-6 of my spine.Stryker should be well aware that when complications were noticed, an immediate emergency, unplanned surgery was performed consisting of multiple attempts to remove the broken fragment of the trocar lodged in my pedicle at t-6, as their sales representative, (b)(4) was present in the operating room during the surgery from the beginning through the end.Dr.(b)(6) had to make an emergency, unplanned incision through and down to my spine, then using a hemostat and metzenbaum scissors made multiple attempts to retrieve the broken fragment of the trocar.During this process severe nerve damage was caused resulting in chronic severe pain 24/7/365 which has affected my physical, mental, emotional and financial over all wellbeing.Stryker had first-hand knowledge of everything that actually occurred since their own sales representative, (b)(4), was in the operating room from the being through the end of the surgery.I was admitted into the in-patient unit of the hospital december 2, 2021, after surgery, for post operative observation and medications for severe pain.I was not stable immediately after surgery or during my overnight stay at the hospital, as i was in more pain after the surgery than before.I was in severe pain as soon as i came out of the anesthesia which required the highest levels of pain medications that were administered near hourly, which offered no relief.As a result of what i feel is stryker's defective equipment, i have consulted with multiple specialists, various pain management doctors, a neurosurgeon, a spine surgeon, been prescribed all kinds of medications, had two surgical series of nerve block spine injections, underwent a surgical procedure for a trial spinal cord stimulator (scs), underwent a surgical procedure for the permanent implant of a spinal cord stimulator (scs) and have been under the care of a mental health therapist, in conjunction with more medications.I am suffering from depression, lack of sleep, anxiety and panic attacks as direct result of the severe chronic 24/7/365 pain.As a result i have been unable to work, unable to drive long distances, unable to participate in a daily exercise routine (yoga, aerobics, walking, riding my outdoor bicycle, riding my indoor stationary bicycle, swimming in my pool and/or workout routine with light weights), unable to socialize with family or friends, all as a result of the excessively severe chronic 24/7/365 pain.Being unable to work has caused financial trauma, as my supplemental income is necessary for my household expenses.I have made every attempt to find a solution to the continued severe 24/7/365 pain that i am experiencing since the surgical complications on december 2, 2021.I believe this has been caused as a direct result of stryker's defective/failed/broke equipment.The trial spinal cord stimulator resulted in an intermittent 30%-40% level of pain relief.Although that is nominal in comparison to the massive amounts of pain that i am in 24/7/365, i felt any relief was better than none.For that reason i opted to suffer through another surgery for the permanent implant of the spinal cord stimulator (scs), which was performed on (b)(6) 2023.As of today i would say i am at 0% intermittent relief from the pain.I am scheduled for a surgical trial pain pump injection to the spine on (b)(6) 2023.If there is any relief from the pain i will be scheduled for surgery to implant a permanent pain pump.Stryker's sales representative, (b)(4), took the defective trocar, stating to dr.(b)(6), that a full investigation with a written report would be provided with recommendations on further surgery or other intervention.

• Brand Name: STRYKER AVAFLEX BALLOON SYSTEM - 11G
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 18173552
• MDR Text Key: 328696116
• Report Number: MW5148300
• Device Sequence Number: 1
• Product Code: NDN
• 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
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 031-115-000
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT (ST. JUDE) SPINAL CORD STIMULATOR IMPLANTED (B)(6) 2023.
• Patient Outcome(s): Life Threatening; Disability; Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White