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

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nausea (1970)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Medical product: depuy synthes skyline anterior cervical plate.Medical product: c5, c6, and c7 screws.Therapy date: (b)(6) 2020.Medical product: zimmer biomet 63b, 72r, and lt-4500 electrodes.Therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient was experiencing nausea while using the spinalpak stimulator.The patient states that within a half hour of using the device, he experienced nausea and vomiting.The symptoms would last all day.The patient places the electrodes just below his ears.The patient reached out to his specialist and was prescribed a medication for the nausea.The patient has since stopped using the device.It was reported that no further information is available.
Event or Problem Description
It was reported that the patient was experiencing nausea while using the spinalpak stimulator.The patient states that within a half hour of using the device, he experienced nausea and vomiting.The symptoms would last all day.The patient places the electrodes just below his ears.The patient reached out to his specialist and was prescribed a medication for the nausea.The patient has since stopped using the device.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The device was not returned to zimmer biomet for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SPINALPAK STIMULATOR
• Common Device Name: NON-INVASIVE, BONE GROWTH, STIMULATOR
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 9900625
• Report Number: 0002242816-2020-00032
• Device Sequence Number: 11454350
• Product Code: LOF
• UDI-Device Identifier: 00812301020225
• UDI-Public: 00812301020225
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P850022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1067717
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention