MAUDE Adverse Event Report: EBI, LLC. SPF-PLUS 60/M; STIMULATOR, INVASIVE BONE GROWTH

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint cmp-(b)(4).The event occurred sometime in (b)(6) 2021.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the patient that he has been in a lot of pain since surgery.The spf was removed in may 2017.The patient stated that his pain was half as bad after the removal of the spf unit.The patient stated that he is still in pain and can hardly walk.The patient stated that there were 2 recalls for the spf; 1st recall was for infection, 2nd recall was for toxic chemicals which caused tissue damage, organ damage and nerve damage.The patient requested spf mri information.*(spf manual emailed to patient) the patient requested a call back to discuss recall, as he would like to forward the information to his doctor to see if he can get rid of the pain.No additional patient consequences have been reported.

Manufacturer Narrative

Corrections - b4: date of this report added, d3: manufacturer address and email address, d4: udi, e: occupation, g1: contact office and manufacturer site, g6: report type additional information - h4: device manufacture date, h6: impact code, method, results, and conclusions, h10: additional narrative, h11.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to (b)(6) 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.(b)(6) medical will continue to monitor for trends.

Event Description

It was reported by the patient that he has been in a lot of pain since surgery.The spf was removed in (b)(6) 2017.The patient stated that his pain was half as bad after the removal of the spf unit.The patient stated that he is still in pain and can hardly walk.The patient stated that there were 2 recalls for the spf; 1st recall was for infection, 2nd recall was for toxic chemicals which caused tissue damage, organ damage and nerve damage.The patient requested spf mri information.*(spf manual emailed to patient) the patient requested a call back to discuss recall, as he would like to forward the information to his doctor to see if he can get rid of the pain.No additional patient consequences have been reported.

• Brand Name: SPF-PLUS 60/M
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• 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: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 12026584
• MDR Text Key: 263470325
• Report Number: 0002242816-2021-00100
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850035/S033
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2024

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 Model Number: N/A
• Device Catalogue Number: 10-1398M
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic