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

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2020.The customer has indicated that the product will not be returned to zimmer biomet for investigation because the patient is still using the product.The investigation is in process.Once the investigation has been completed, a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002242816-2020-00012 and 0002242816-2020-00013.The device was not returned.
Event or Problem Description
It was reported that the patient was experiencing pain from the spinalpak stimulator.The patient was using the spinalpak stimulator with the lt-4500 and 72r electrodes.The patient stated that the pain was on the right side of her back in the kidney area and across the hip.The patient stated that the pain is below the skin and the pain level is a 10, on a scale of 1-10.The patient stopped using the stimulator and the pain did not go away.The patient called their doctor and was prescribed ibuprofen and advised not to use the stimulator for a week.The patient believes that the pain was from the inflammation of the incision.No additional patient consequences have been reported.
Event or Problem Description
It was reported that the patient was experiencing pain from the spinalpak stimulator.The patient was using the spinalpak stimulator with the lt-4500 and 72r electrodes.The patient stated that the pain was on the right side of her back in the kidney area and across the hip.The patient stated that the pain is below the skin and the pain level is a 10, on a scale of 1-10.The patient stopped using the stimulator and the pain did not go away.The patient called their doctor and was prescribed ibuprofen and advised not to use the stimulator for a week.The patient believes that the pain was from the inflammation of the incision.It was reported that 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.The following sections have been updated: b4: date of this report added g4: date received by manufacturer added g7: type of report h2: follow up type h3: device evaluated by manufacturer updated to no h4: device manufacturer date added h6: method code updated to 3331: analysis of production records h6: method code updated to 4114: device not returned h6: results code updated to 3221: no findings available h6: conclusions code updated to 4315: cause not established h10: additional narratives/data.The following sections have been corrected: d4: serial number corrected.

• Brand Name: SPINALPAK STIMULATOR, BIOMET
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 9627139
• Report Number: 0002242816-2020-00014
• Device Sequence Number: 19625312
• Product Code: LOF
• UDI-Device Identifier: 00812301020225
• UDI-Public: 00812301020225
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 01/24/2020
• 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
• Patient Weight: 98