MAUDE Adverse Event Report: PARADIGM SPINE GMBH COFLEX INTERLAMINAR TECHNOLOGY; PROSTHESIS, SPINOUS PROCESS SPACER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Urinary Retention (2119); Numbness (2415)

Event Date 05/20/2014

Event Type  No Answer Provided  

Event Description

The fda forwarded a report mw5058446 to paradigm spine, llc.The following section summarizes the information provided within aforementioned report.2014, the patient consulted the surgeon for a surgical resolution of extreme lower back pain due to severe degenerative facet arthropathy at l5-s1 with spinal stenosis and a contained disc herniation at l4-l5 with mild facet irritation.A coflex implant was implanted in l5-s1 on (b)(6) 2014.At home, the patient noticed that she was completely numb in her left saddle area and had to strain to urinate.17 months post-op, she continues to suffer from pudendal neuralgia/ces on the left side.She is able to urinate with strain, and she cannot feel the left side of her vagina.One problem that has worsened is her bowel function.The patient is very disappointed.She reported: she is a female, a mother, and she works full-time.Her symptoms have worsened and her back pain is returning.She has trouble finding a physician that will help her and she refuses to go back to her initial doctor.She is suffering physically and emotionally from this ordeal.This is not the quality of life she expected at her age.

Event Description

The fda forwarded a report mw5058446 to paradigm spine, llc.The following section summarizes the information provided within aforementioned report.In 2014, the patient consulted the surgeon for a surgical resolution of extreme lower back pain due to severe degenerative facet arthropathy at l5-s1 with spinal stenosis and a contained disc herniation at l4-l5 with mild facet irritation.A coflex implant was implanted in l5-s1 on (b)(6) 2014.At home the patient noticed that she was completely numb in her left saddle area and had to strain to urinate.Seventeen months post-op, she continues to suffer from pudendal neuralgia/ces on the left side.She is able to urinate with strain, and she cannot feel the left side of her vagina.One problem that has worsened is her bowel function.The patient is very disappointed.She reported: she is a female, a mother, and she works full-time.Her symptoms have worsened and her back pain is returning.She has trouble finding a physician that will help her and she refuses to go back to her initial doctor.She is suffering physically and emotionally from this ordeal.This is not the quality of life she expected at her age.The patient explains that two years and four months post-op, she still experiences the same numbness in her left saddle region, strain to urinate as her bladder does not empty completely, thus making her prone to urinary tract / bladder infections.The rectal bleeding was determined to be from an ulcer.The pain in her back increased to a pain score of five to six.She has trouble sleeping, working and performing daily functions.She cannot find a doctor who will help her.

Manufacturer Narrative

The surgeon was contacted to gather information about this case.The surgeon reported that he could not remember the patient having a bad result.He recalls patient had pre-op bladder complaints.According to him post-op symptoms are not related to the surgery.

Event Description

The fda forwarded a report mw5058446 to paradigm spine, llc.The following section summarizes the information provided within aforementioned report.In 2014, the patient consulted the surgeon for a surgical resolution of extreme lower back pain due to severe degenerative facet arthropathy at l5-s1 with spinal stenosis and a contained disc herniation at l4-l5 with mild facet irritation.A coflex implant was implanted in l5-s1 on (b)(6) 2014.At home the patient noticed that she was completely numb in her left saddle area and had to strain to urinate.Seventeen months post-op, she continues to suffer from pudendal neuralgia/ces on the left side.She is able to urinate with strain, and she cannot feel the left side of her vagina.One problem that has worsened is her bowel function.The patient is very disappointed.She reported: she is a female, a mother, and she works full-time.Her symptoms have worsened and her back pain is returning.She has trouble finding a physician that will help her and she refuses to go back to her initial doctor.She is suffering physically and emotionally from this ordeal.This is not the quality of life she expected at her age.The fda forwarded a follow-up report mw5058446 to paradigm spine, llc.The following section summarizes the information provided within aforementioned report.The patient explains that two years and four months post-op she still experiences the sam numbness in her left saddle region, strain to urinate as her bladder does not empty completely, thus making her prone to urinary tract / bladder infections.The rectal bleeding was determined to be from an ulcer.The pain in her back increased to a pain score of five to six.She has trouble sleeping, working and performing daily functions.She cannot find a doctor who will help her.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER
• Manufacturer (Section D): PARADIGM SPINE GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• Manufacturer (Section G): PARADIGM SPINE GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• Manufacturer Contact: alberto jurado ; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573 ; 9746196359
• MDR Report Key: 5403564
• MDR Text Key: 37269430
• Report Number: 3005725110-2016-00001
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• PMA/PMN Number: P110008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2017

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?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 02/02/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/22/2017; 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other