• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SUPPORT BAR PECTUS BAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET MICROFIXATION PECTUS SUPPORT BAR PECTUS BAR Back to Search Results
Model Number N/A
Device Problem Biocompatibility (2886)
Patient Problems Dehydration (1807); Increased Sensitivity (2065); Vomiting (2144)
Event Type  Injury  
Event Description
The legal document states the patient is unable to finish school, work, or take care of herself. The patient had a consult with another surgeon who stated a third surgery could be a dangerous and fatal and is not a viable option right now due to the scar tissue she currently has due to the complications that the prior surgery placed on her organs. It is stated there is a strong possibility the patient will never recover from the complications of the surgery and the allergic reaction she suffered from, that she will never be able to have kids and will be rendered severely disabled for the rest of her life.
 
Manufacturer Narrative
Zimmer biomet complaint (b)(4). This follow-up report is being submitted to relay additional information. These parts were removed in a revision; therefore the complaint is considered confirmed. Investigation results concluded that the reported event was due to patient condition. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. (b)(4).
 
Event Description
It was reported via the receipt of additional legal documents that upon one of the visits to the emergency room she was prescribed prevacid, a proton pump inhibitor, after other anti-nausea medications were tried. She showed symptoms of a serious reaction to prevacid, including high heart rate and watery diarrhea. She needed frequent emergency room visits for headache, high heart rate, and dehydration. It was reported the patient was admitted to the hospital and tested for c-diff. It was not a viable sample, but she tested positive and was treated for c-diff. She took vancomycin for approximately two months. When her vancomycin dose was doubled she began to break out in red, itchy spots all over her body from the waist up. She had diarrhea several times daily while the bars were in, which stopped immediately when they were removed. She began to smell very badly from her chest cavity. The surgeon who removed the bars washed her chest cavity out with antibiotic wash. The patient's chest pain and digestive complaints and headaches were resolved as soon as the bars were removed. Her tachycardia and erratic heart rate, not present in testing before the bars were placed, has been present ever since and severely limits her daily function. She has been diagnosed with an auto-immune disorder, triggered by her systemic allergic reaction. When her heart pounds, her pounding headaches and temporary loss of vision in one eye increases. Her physical therapists have noted that cardiovascular problems limit the physical therapy she can do, as well as daily activities. She cannot return to her polycystic ovary syndrome (pcos) medication, which should have been discontinued for surgery and she discontinued after surgery because of constant, severe chest pain, because she can no longer tolerate it. Her blood pressure increases now when she takes it. Without her pcos medication , she continues to suffer pain. Pcos can cause heart damage and diabetes if left untreated. She had to eliminate all animal products from her diet as well. Side effects of the many medications she was given while reacting to the bars, some against her expressed will, can be heart damage.
 
Manufacturer Narrative
(b)(4). The part and lot numbers are unknown, therefore the device history records are unable to be reviewed. The package insert for this device lists "patients presenting metal sensitivity reactions" as a contraindication. Metal sensitivity reactions or allergic reaction to the implant material are listed as possible adverse effects. If additional information is obtained that adds value to the relevant content of this report a follow-up report will be sent.
 
Event Description
A legal claim was received which indicated the patient had a revision due to an allergic reaction. The document states the surgery to place two pectus bars was performed (b)(6) 2015. The patient was inpatient for a week after the procedure. The patient was still nauseous and could not tolerate pain medicine or control urinating. The patient was in severe pain after the surgery and at one point her respiratory function severely decreased. After the bars were implanted the patient experienced more difficulty breathing and suffered from severe headaches. The patient experienced pain when urinating; the doctor prescribed septra as it sounded like a urinary tract infection. The patient reported throwing up constantly while taking septra. The patient made several trips to the emergency room due to her symptoms. It is reported based on the patient's symptoms no allergy test was performed. At one point the patient could no longer keep water down and was suffering from dehydration. It is reported she was diagnosed with anxiety and referred to a psychiatrist. The patient continued to get weaker, had increasing joint pain, continued to have severe headaches, and continued to have problems breathing, and she had developed a rash from the waist up. The patient was seen by a different physician who performed a test for allergic reactions to the metal bars which tested positive to sensitivity to the components in the bars. As a result, the bars were removed in (b)(6) 2016. After the surgery the patient's rash immediately faded, her headaches were gone as well as her chest and joint pain. It is reported the patient is still suffering from the same complications she was suffering from prior and the results are more severe than they were prior to surgery. The compression in her lungs is worse and she is rendered unable to do anything she was able to do prior and her immune system has lowered. She has now been confined to a recliner.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePECTUS SUPPORT BAR
Type of DevicePECTUS BAR
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer (Section G)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer Contact
michelle cole
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key7028103
MDR Text Key113782030
Report Number0001032347-2017-00803
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK972420
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/14/2017 Patient Sequence Number: 1
-
-