MAUDE Adverse Event Report: PARADIGM SPINE COFLEX IMPLANT; SPINAL INTERLAMINAL FIXATION PROSTHESIS

Device Problem Nonstandard Device (1420)

Patient Problems Emotional Changes (1831); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Inflammation (1932); Pain (1994); Pain (1994); Urinary Retention (2119); Therapeutic Response, Decreased (2271); Therapeutic Response, Decreased (2271); Ulcer (2274); Numbness (2415); Numbness (2415); Sleep Dysfunction (2517); Dysuria (2684); Dysuria (2684); Constipation (3274); Constipation (3274)

Event Date 05/20/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, i consulted with dr.(b)(6) of the (b)(6) for a surgical resolution to extreme lower back pain due to severe degenerative facet arthropathy at l5-s1 with spinal stenosis and a small contained disc herniation at l4-l5 with mild facet irritation.I had been suffering with lower back pain for four years at the time of this appointment.I was presented with two options, a fusion and a coflex implant.After seeing and discussing the benefits of the coflex implant with dr.(b)(6), i agreed to have the implant, once the procedure was approved by my insurance company.I did ask dr.(b)(6) if the device was approved by the fda in which he replied, "yes." his surgery coordinator, (b)(6), came into the office and stated that the procedure was approved by my insurance company, so i scheduled the surgery for (b)(6) 2014.On (b)(6) 2014, i had the outpatient surgery at dr.(b)(6) surgery center where a coflex implant was inserted between l5-s1.My father took me home shortly after recovery.After arriving home, i felt the urge to urinate.I noticed that i was completely numb in my left saddle area and had to strain to urinate.After a few hours, i called the office and spoke to (b)(6).I asked if they had used a local anesthesia in which he replied "no." i explained my symptoms of numbness in my left saddle area and trouble using the bathroom.He prescribed a medrol dosepak explaining to me that it may be due to inflammation from the surgery.The medrol dosepak did not help.I continue to this day, 17 months post-op, to suffer from pudendal neuralgia/ces on the left side.I am able to urinate with strain, and i cannot feel the left side of my vagina.One problem that has worsened is my bowel function.In 2003, i underwent surgery for an anal fissure on my right side.Being that i cannot feel the left side of my lower colon/anus and the surgical changes to the right side of my sphincter in 2003, i am unable to defecate without coaxing the stool out using the inside wall of my vagina.For the last two months, i have noticed bleeding after defecation and am assuming it is from the repair of my anal fissure.I have yet to seek medical advise on this matter.In (b)(6) 2014, i was notified by the billing department that my insurance did not cover the coflex implant, because they considered it an experimental device.I was shocked when i saw the ledger balance of (b)(4).I would never financially burden my family in this regard and would have opted for a fusion had i known.I tried diligently over the next several months to work out with the billing department.The amount has been decreased to (b)(4) which i still do not find acceptable seeing that i never had the knowledge the device was experimental nor did i consent to an experimental device being placed in my spine that was currently under two pmas, as i discovered later.Three people from the billing department admitted that they believed (b)(6) told me the procedure would be covered.I have it in writing from the office manager that i would not be responsible for the amount.I requested my medical records for review.I am upset to find that many of the records inaccurate.It does not appear that the physician has filed an based on what has happened to me.Today, i discovered report #3005725110-2014-00006 in which a pt had somewhat similar complications.Based on the manufacturer narrative, the coflex is not intended for use in l5-s1, exactly where mine is located.I am a (b)(6) female, a wife, a mother, and i work full-time.My symptoms have worsened, and my back pain is returning.I am having trouble finding a physician that will help me.And i refuse to go back to (b)(6) for obvious reasons.I am suffering physically and emotionally from this ordeal.This is not the quality of life i expected at my age.

Event Description

Add'l info received from reporter on 01/17/2017: i am now two years and four months post-op.I am still experiencing the same numbness in my left saddle region.I strain to urinate as my bladder does not empty completely, thus, making me prone to urinary tract/bladder infections.Unfortunately, these infections are caught only after i have become very sick.The rectal bleeding was determined by my rectal surgeon to be from an ulcer caused by the manual manipulation of stool using the vaginal wall.I am unable to detect bowel movements and have defecated in my pants.The pain in my back has increased to a pain level of five to six.I am having trouble sleeping, working and performing daily functions.I cannot find a doctor who will help me.Paradigm spine, who recently settled a false claims allegation with the us department of justice for pushing "off-label-use," is planning my spine surgeon for using the device "off-label." my surgeon has done nothing but make matters worse by turning my balance over to collections.

Event Description

Additional information received from reporter on 04/28/2017 for report mw5058446: patient response to manufacturer narrative for mw5058446.Paradigm spine with dr.(b)(6) has provided a false narrative.The patient has medical documentation and witnesses that negate the narrative provided.

• Brand Name: COFLEX IMPLANT
• Type of Device: SPINAL INTERLAMINAL FIXATION PROSTHESIS
• Manufacturer (Section D): PARADIGM SPINE
• MDR Report Key: 5290585
• MDR Text Key: 33361451
• Report Number: MW5058446
• Device Sequence Number: 1
• Product Code: NQO
• 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,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 75