MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Injury (2348); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore, the device history records are unable to be reviewed.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.

Event Description

The patient reported undergoing a procedure in (b)(6) 2008 to repair a ruptured disk and an implantable bone stimulator was utilized following the procedure.Subsequently, patient reports allegations of pain and a lump in the location of the implanted bone stimulator.Patient further alleges the stimulator was removed in (b)(6) 2010, but alleges that a portion of the stimulator remains implanted based on alleged mri evidence.Patient further alleges that screws, rods and plates from an unknown manufacturer remain implanted.Patient alleges damage to organs and tissue for which patient is allegedly being treated by a pain management physician.This report is based on patient's allegations the above allegations have not been verified.

• Brand Name: SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
• Type of Device: IMPLANTABLE SPINAL FUSION STIMULATOR
• 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: 5081829
• MDR Text Key: 25992662
• Report Number: 3004485144-2015-00052
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP850035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Report Date: 08/18/2015

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: 10-1335M
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2015
• 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: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability