MAUDE Adverse Event Report: SPINE WAVE, INC. PS3 CAPSURE SPINAL SYSTEM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number 11-3000(6),11-3642(6),11-3051(

Device Problems Break (1069); Loose or Intermittent Connection (1371); Material Protrusion/Extrusion (2979)

Patient Problems Bruise/Contusion (1754); Headache (1880); Incontinence (1928); Itching Sensation (1943); Pain (1994); Swelling (2091); Burning Sensation (2146); Tingling (2171); Depression (2361); Numbness (2415); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 06/28/2016

Event Type  Injury  

Event Description

Pt called to report adverse events involving her ps3 spinal system she had implanted on (b)(6) 2014.Pt stated that after the initial surgery she felt good.Pt said one day she woke up and couldn't walk or stand, and her physician said it was because she had loosening of the device and broken hardware.Pt said she had a revision surgery on (b)(6) 2016 to fix the problems, but never felt relief after this surgery.Pt said she continually just kept getting worse, having pain, and couldn't move or stand.Pt said she kept insisting to her physician that something was not right.Pt said she had a second revision surgery on (b)(6) 2017 which only caused her even more problems.Pt's symptoms are: itching, swelling at incision site, raw spots, burning feeling, incontinence, can't sit, walk or stand for a long amount of time, constant extreme pain, tingling and numbness in hands, legs and feet, legs look purple, bruising, headaches, metal taste in mouth, ruined sex drive, and depression.Pt stated she requested a device info card from physician, but the physician refused and then terminated her as a pt.Pt said she strongly feels the physician is to blame for faulty procedures and/or faulty devices.Pt said her issues with the devices were broken screws that couldn't be removed, loosening, failure to fuse, iliac bolt caps protruding on both sides of the lower spine, and a reaction to the hardware.She is planning to take legal action against physician.

• Brand Name: PS3 CAPSURE SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): SPINE WAVE, INC. ; three enterprise dr. ; ste 210; shelton CT 06484
• MDR Report Key: 8139571
• MDR Text Key: 129616288
• Report Number: MW5081899
• Device Sequence Number: 1
• Product Code: MNH
• 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: 12/05/2018
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 11-3000(6),11-3642(6),11-3051(
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR