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

Catalog Number 10-1335W

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Type  Injury  

Event 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.

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.

• Brand Name: SPAF-XL-IIB 2/DW
• Type of Device: SPF IMPLANTABLE
• 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
• MDR Text Key: 338070637
• Report Number: 0002242816-2024-00036
• Device Sequence Number: 1
• Product Code: LOE
• UDI-Device Identifier: 00812301020096
• UDI-Public: 00812301020096
• Combination Product (y/n): N
• Reporter Country Code: US
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2024

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
• Device Operator: Other
• Device Catalogue Number: 10-1335W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic