MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); VBR, BULLET-TIP

Model Number 32-10-22

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Headache (1880); Incontinence (1928); Itching Sensation (1943); Swelling (2091); Tingling (2171); Depression (2361); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

On january 13, 2019, the patient called and notified rti surgical, inc.(rti) of a diagnosis of failure to fuse as part of the patient's referral and evaluation by staff at (b)(6) medical.The patient was seeking potential removal and replacement of retained spinal hardware (not manufactured by rti).The patient has undergone three spinal surgeries of the lumbosacral region.The patient had contacted rti surgical in november and december of 2018 for assistance in identifying the materials in the rti implants utilized in the patient's prior surgeries as part of testing the patient was planning on undergoing to identify potential metal allergies to the patient's spinal hardware.The patient filed a voluntary medwatch report on 12/05/2018, #mw5081899, related to complications experienced with the hardware.Rti surgical was unaware of the medwatch being filed on 12/05/2018 and unaware that rti surgical's device were involved.The patient is the initial reporter of this event.The devices referred to on the mw5081899 do not match the devices the patient reported to rti surgical on january 13, 2019.Devices were not returned to rti surgical.As of the date of this report, to rti surgical's knowledge, the devices remain in the patient.

Event Description

On january 05, 2018, the patient reported to the fda the following under mw5081899: "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." according to the mw report the event date was (b)(6) 2016.On january 13, 2019, the patient reported to rti surgical that she had filed mw5081899.

• Brand Name: PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL)
• Type of Device: VBR, BULLET-TIP
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 8331869
• MDR Text Key: 135910396
• Report Number: 1833824-2019-00003
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K133455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2015
• Device Model Number: 32-10-22
• Device Catalogue Number: SAME
• Device Lot Number: 082927
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention