MAUDE Adverse Event Report: EBI, LLC. SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR; SPF-XL IIB 2/DW

Model Number	10-1335W
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced severe pain with the zimmer biomet spf xl iib 2/dw implant, and the mri performed by grossman imaging center.The spf xl iib 2/dw was implanted in a lumbar surgery in 2017 by (b)(6).The summer of 2021 the patient visited (b)(6) for an mri prior to implant removal surgery.It was stated that "zimmer biomet negligently evaluated the safety of the bone stimulator and had insufficient data to justify the spf xl iib 2/dw bone stimulator being labels as conditionally safe, especially once more powerful mris began to be commonly used.Further, defendant zimmer biomet negligently designed the bone stimulator such that its electrical conductivity was greater than represented in its warnings and marketing materials." limas, a patient with a back condition, was scanned by a technician about the presence of a bone stimulator.The imaging center was informed about this and a c-t study had been done at (b)(6) two weeks earlier.Limas was prepared for the mri, but after the exam, he began screaming in pain and was asked to sit quietly.The technician instructed him to take pain medication from defendant arche the following day and to retry the mri two days later.Limas felt better after resting at the imaging center and left, but his back pain worsened.The mri machine was activated, and limas experienced the worst pain he had ever experienced.He was terrified and crying, and his back and legs burned.He was discharged from the imaging center.Over the next few weeks, limas experienced increasingly severe pain in his legs, weaker legs, and incontinence.He did not associate his deteriorating condition with the mri, as he had had an mri prior to his 2017 surgery and did not have any problems with it.No additional information has been reported at this time.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow up report will be sent.
Additional Manufacturer Narrative
Corrections in b4: date of the report, d3: manufacturer, d1: brand name, d2a: device common name, d4: model number, expiration date, g1: contact office, g6: type of report, h2, h8, h5: labeled for single use.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical 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.Highridge medical will continue to monitor for trend.
Event or Problem Description
It was reported that the patient experienced severe pain with the zimmer biomet spf xl iib 2/dw implant, and the mri performed by grossman imaging center.The spf xl iib 2/dw was implanted in a lumbar surgery in 2017 by artulo aroche jr, do.The summer of 2021 the patient visited grossman imaging center for an mri prior to implant removal surgery.It was stated that "zimmer biomet negligently evaluated the safety of the bone stimulator and had insufficient data to justify the spf xl iib 2/dw bone stimulator being labels as conditionally safe, especially once more powerful mris began to be commonly used.Further, defendant zimmer biomet negligently designed the bone stimulator such that its electrical conductivity was greater than represented in its warnings and marketing materials." limas, a patient with a back condition, was scanned by a technician about the presence of a bone stimulator.The imaging center was informed about this and a c-t study had been done at grossman's two weeks earlier.Limas was prepared for the mri, but after the exam, he began screaming in pain and was asked to sit quietly.The technician instructed him to take pain medication from defendant arche the following day and to retry the mri two days later.Limas felt better after resting at the imaging center and left, but his back pain worsened.The mri machine was activated, and limas experienced the worst pain he had ever experienced.He was terrified and crying, and his back and legs burned.He was discharged from the imaging center.Over the next few weeks, limas experienced increasingly severe pain in his legs, weaker legs, and incontinence.He did not associate his deteriorating condition with the mri, as he had had an mri prior to his 2017 surgery and did not have any problems with it.No additional information has been reported at this time.The spf-xl iib 2/dw was not returned for further evaluation.

• Brand Name: SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
• Common Device Name: SPF-XL IIB 2/DW
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 18938236
• Report Number: 0002242816-2024-00036
• Device Sequence Number: 12523227
• Product Code: LOE
• UDI-Device Identifier: 00812301020096
• UDI-Public: 00812301020096
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: Other
• Device Expiration Date: 07/20/2018
• Device Model Number: 10-1335W
• Device Catalogue Number: 10-1335W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic