MAUDE Adverse Event Report: EBI, LLC. SPF-XL IIB 2/DM; EBI SPF-XL IIB BONE GROWTH STIMULATOR

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products- percocet, zetia, amitriptyline, tizanidine, centrum, probiotics.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once he investigation is completed, a supplemental medwatch 35000a will be submitted.
Event or Problem Description
It was reported that the patient experienced symptoms of nerve pain, chronic pain, swelling, inflammation and also infection.The patient had the spf device implanted for 12 years.The patient also stated that she had urine problems, could not empty her bladder, and had to use antibiotic for pain.The patient stated that no physician would remove the device.The patient stated that she had the device removed earlier this year by a pain management doctor.The patient stated that after explanation of the device, the infections and horrible pain cleared, and the ability to live is coming back.The patient indicated that she continues to use antibiotics and that she is going to pain management.The patient wanted to know whether there was a recall on the spf model that she was treated with.No additional patient consequences were reported.
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 (dhr) was reviewed and no discrepancies were found.The root cause was unable to be determined as the necessary information to adequately investigate the reported condition 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 were updated: h6: device code updated to 3190: insufficient information.H6: method code updated to 4114: device not returned.H6: method code updated to 3331: analysis of production records.H6: results code updated to 3221: no findings available.H6: conclusions code updated to 4315: cause not established.H3 other text : the device has not been returned.
Event or Problem Description
It was reported that the patient experienced symptoms of nerve pain, chronic pain, swelling, inflammation and also infection.The patient had the spf device implanted for 12 years.The patient also stated that she had urine problems, could not empty her bladder, and had to use antibiotic for pain.The patient stated that no physician would remove the device.The patient stated that she had the device removed earlier this year by a pain management doctor.The patient stated that after explanation of the device, the infections and horrible pain cleared, and the ability to live is coming back.The patient indicated that she continues to use antibiotics and that she is going to pain management.The patient wanted to know whether there was a recall on the spf model that she was treated with.No additional patient consequences were reported.

• Brand Name: SPF-XL IIB 2/DM
• Common Device Name: EBI SPF-XL IIB BONE GROWTH STIMULATOR
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 8627837
• Report Number: 0002242816-2019-00016
• Device Sequence Number: 2232527
• Product Code: LOE
• UDI-Device Identifier: 00812301020089
• UDI-Public: 00812301020089
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P850035/S023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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 Expiration Date: 07/21/2008
• Device Model Number: N/A
• Device Catalogue Number: 10-1335M
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 12/09/2019
• 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; Disability