MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD SPF-PLUS IMPLANTABLE STIMULATOR

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

The physician's manual states "the generator may optionally be removed at the end of its useful life (approximately 24-weeks)." the full prescribing information states "indications:the spf plus-mini implantable fusion stimulator is indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.The spf-xl iib implantable spinal fusion stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 3 or more levels.Usage:the spf has only been studied as an adjunct for lumbar spinal surgery." review of device history records show the lot released with no recorded anomaly or deviation.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.

Event Description

Received the facility medwatch report which states "the patient had a bone graft stimulator implanted approximately one year ago.The physician requested to remove the stimulator as it was not effectively progressing growth of the bone.This stimulator was not replaced at this time.No known injury occurred to the patient.".

• Brand Name: SPF-PLUS IMPLANTABLE STIMULATOR
• Type of Device: SPF
• 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
• MDR Report Key: 5903427
• MDR Text Key: 52969986
• Report Number: 3004485144-2016-00196
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2016
• Device Model Number: N/A
• Device Catalogue Number: 10-1398M
• Device Lot Number: 407907
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 42 YR