MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD POLARIS SPINAL SYSTEM; TITANIUM ALLOY ROD

Model Number N/A

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Information (3190)

Event Date 08/01/2014

Event Type  Injury  

Event Description

Legal counsel for the patient reported that on (b)(6) 2012 the patient underwent a laminotomy at t12-l1 and placement of posterior spinal instrumented fusion t9-l3 pedicle screws with a 5.5mm titanium fusion rod with derotation.Legal counsel for patient alleges bi-lateral transpedicle screw fractures at l3.Legal counsel further reports that the patient underwent corrective surgery on (b)(6) 2014.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report six of seven for the same event, see also 3004485144-2015-00021, 3004485144-2015-00022, 3004485144-2015-00023, 3004485144-2015-00024, 3004485144-2015-00025 and 3004485144-2015-00027.

Manufacturer Narrative

Supplemental report six of seven for the same event, see also 3004485144-2015-00021-1 through 3004485144-2015-00027-1.

Event Description

Legal counsel for the patient reports on or about (b)(6) 2012, the patient was examined for the diagnosis and management of back pain, bilateral leg pain, difficulty sleeping, spinal asymmetry and related problems.The patient was diagnosed with atypical scoliosis.It is reported soon after the (b)(6) 2012 surgery the patient started experiencing back pain.On or about (b)(6) 2014, films were ordered which confirmed that the patient sustained bi-lateral transpedicular screw fractures at l2-3.Legal counsel further reports the patient has undergone two subsequent corrective surgeries.She has also been treated by other health care providers.The surgeries and treatments have not corrected the injury and the patient continues to suffer from chronic pain and is expected to do so for the remainder of her life.No information has been provided regarding the additional surgeries or treatments.

• Brand Name: POLARIS SPINAL SYSTEM
• Type of Device: TITANIUM ALLOY ROD
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 4963346
• MDR Text Key: 6253581
• Report Number: 3004485144-2015-00026
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/09/2015

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2000-5405
• Device Lot Number: 696280
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 08/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention