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

Model Number N/A

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

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient is having increased pain surrounding the treatment area.The patient stated the pain started on (b)(6).The patient woke with the pain, and it got progressively worse as the day went on.The pain was a little bit in the lower back, both upper hips, the pelvic area, and soft tissue in the pelvic area.The pain was below the skin.The pain level was a 9; the patient could barely move in his bed.The patient had not increased his daily activity.The patient left a message for the doctor.He's not taking anything for the pain.He was using the unit for 9 to 10 hours a day.The patient stopped using the stimulator on tuesday.The pain did not go away when the patient stopped using the stimulator.The physical therapist told the patient that his progress regressed 3 to 4 weeks.The patient stated that he was told that the bone was fusing every month since the surgery.He is not sure why he needs to use the stimulator.The patient is waiting for the doctor to call him back.Customer service offered to send the patient a new assembly bag to replace the one he has now, but he told them to wait until he hears from his doctor first.He will call back with an update.It was later reported on (b)(6) 2022 that customer service received a call from sales representative who stated that the patient is not going to continue the treatment.The patient's doctor told them that it was up to them if they wanted to continue the treatment or not.The patient is not returning the product.No further information has been reported at this time.

Manufacturer Narrative

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.Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: spinal pak bone stimulator.Therapy date: unknown.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINAL PAK, 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: 14788988
• MDR Text Key: 294856528
• Report Number: 0002242816-2022-00063
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020218
• UDI-Public: 00812301020218
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1067716
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male