MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD EBI SPF® IMPLANTABLE SPINAL FUSION STIMULATOR; BONE STIMULATOR

Model Number N/A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The part number and lot number are 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.Remains implanted.

Event Description

The mri technician reported a patient with a possible broken lead.The patient's neurosurgeon, who was treating the patient for headaches, ordered an mri.The mri technician identified a possible broken lead, therefore the mri could not be completed.Upon follow up with the patient she stated that she was implanted with the bone stimulator in 2010 or 2011 at l5-l1 at the fusion.In addition, she reported she was unaware of any issues until the mri appointment.The physician manual for this product states " "the generator may optionally be removed at the end of its useful life (approximately 24-weeks)." it is unknown when the lead broke as it has been implanted with no known issues since 2010 or 2011.

• Brand Name: EBI SPF® IMPLANTABLE SPINAL FUSION STIMULATOR
• Type of Device: BONE 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: 5323036
• MDR Text Key: 34920312
• Report Number: 3004485144-2015-00116
• 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: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/23/2015
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1