MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number N/A

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

Patient Problems Headache (1880); Tachycardia (2095); Palpitations (2467)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Full pma number: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient experienced a racing heart, heart palpitations, and headaches while treating with the spinalpak assembly.An emergency room visit was mentioned but no details were provided.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No additional information, x-rays, scans, pictures, or physician's reports were provided; and no product was returned for evaluation.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 7181816
• MDR Text Key: 96951331
• Report Number: 0002242816-2018-00001
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• PMA/PMN Number: PP850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• 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: 1067716
• Device Lot Number: N/A
• Other Device ID Number: (01)00812301020218(21)L49429
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention