MAUDE Adverse Event Report: EBI, LLC. SPINALPAK BONE STIMULATOR, BIOMET

Model Number N/A

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

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

The product is still being used by the patient and therefore will not be returned for an evaluation.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

It is reported that the patient is experiencing a "swelling/ lump/ bubble" on either side of the clavicle the size of a tennis ball while using the spinalpak.The patient states it is painful when he presses down on it.The patient advised that he had no issues for approximately a month of wearing the unit.The patient stated he went to his doctor on (b)(6) 2016 and his doctor did not prescribe any medication for him.The patient says his doctor advised him to wear the unit for 24 hours without taking a break despite the swelling.The doctor advised him to take ibuprofen if he needed pain relief.The patient stated the last time he took muscle relaxer was 2 weeks prior to (b)(6) 2016.

Manufacturer Narrative

Udi #: (b)(4).Review of the device history records show that the device was released with no recorded anomaly or deviation.Based on the additional information received, the following were updated: model/lot #, date received by mfr, if follow-up, what type?, device manufacture date, and additional mfr narrative.

• Brand Name: SPINALPAK BONE STIMULATOR, BIOMET
• Type of Device: SPINALPAK
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: michelle cole ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 6000216
• MDR Text Key: 56485314
• Report Number: 0002242816-2016-00030
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1067717
• Device Lot Number: N/A
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2016
• Is the Device Single Use?: No
• 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): Other