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

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: titanium cage with morcellized allograft.Therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
Shooting pain down leg.It was reported that the patient was experiencing pain while using the spinal pak.The patient described it as shooting pains down her leg below the skin.The pain subsided when the patient removed the spinal pak.The patient rated the pain as a 6 on a scale of 1 to 10, with 8 or 9 being the highest.The patient states that she has not increased her daily activities.The patient advised her to take flexeril and tylenol for the pain.It was reported that no further information is available.
Event or Problem Description
It was reported that the patient was experiencing pain while using the spinal pak.The patient described it as shooting pains down her leg below the skin.The pain subsided when the patient removed the spinal pak.The patient rated the pain as a 6 on a scale of 1 to 10, with 8 or 9 being the highest.The patient states that she has not increased her daily activities.The patient was advised by her doctor to take flexeril and tylenol for the pain.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: b4: date of this report added g1-2: contact office updated g3: date received by manufacturer added g6: type of report h2: follow up type h3: device evaluated by manufacturer updated to no h4: device manufacturer date added h6: health effect updated 1994-pain h6: device code updated to 2993: adverse event without identified device or use problem h6: investigation code added to 4114: device not returned h6: investigation code added to 4119: insufficient information available h6: investigation code added to 3331 - analysis of production records h6: investigation findings code added to 3221: no findings available h6: investigation conclusions code updated to 4315: cause not established h10: additional narratives/data the following sections have been corrected: b5: describe event or problem.

• Brand Name: SPINALPAK ASSEMBLY
• Common Device Name: STIMULATOR, SPINE FUSION STIMULATOR, NON-INVASIVE
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 10872206
• Report Number: 0002242816-2020-00123
• Device Sequence Number: 16803294
• Product Code: LOF
• UDI-Device Identifier: 00812301020225
• UDI-Public: 00812301020225
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P850022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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 Sex: Female