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

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); 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.Medical product: peek roi-a cage.Medical product: two 13 mm vertebridge alloy plates.Therapy date: (b)(6) 2018.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 complained of pain from the spinalpak stimulator.The patient was using the device on their lumbar spine.The patient stated that using the spinalpak caused her back pain to become worse.The patient reported that the pain was on average a 5, on a scale of 1 to 10.The patient said that the pain level can increase up to an 8 or 9.When the patient started to experience more pain, the patient discontinued use of the spinalpak stimulator.The patient reported that the intense pain has not decreased since discontinuing treatment with the unit.The patient is waiting for the doctor's office to reach out for a follow up appointment.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected 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: h3: device evaluated by manufacturer updated to no.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.The following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.
Event or Problem Description
It was reported that the patient complained of pain from the spinalpak assembly.The patient was using the device on their lumbar spine.The patient stated that using the spinalpak caused her back pain to become worse.The patient reported that the pain was on average a 5, on a scale of 1 to 10.The patient said that the pain level can increase up to an 8 or 9.When the patient started to experience more pain, the patient discontinued use of the spinalpak.The patient reported that the intense pain has not decreased since discontinuing treatment with the unit.The patient is waiting for the doctor's office to reach out for a follow up appointment.Attempts have been made and no further information has been provided.

• Brand Name: SPINALPAK ASSEMBLY
• Common Device Name: NON-INVASIVE, BONE GROWTH, STIMULATOR
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 10088478
• Report Number: 0002242816-2020-00053
• Device Sequence Number: 3081515
• Product Code: LOF
• UDI-Device Identifier: 00812301020225
• UDI-Public: 00812301020225
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/27/2020

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: 1067716
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 08/27/2020
• 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