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

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported there was a revision due to infection.The surgeon states the anticipated removal of the device was (b)(6) 2016, however the patient developed a deep infection from the implant.The surgeon reports the explant procedure went well.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is considered confirmed as there was a revision due to infection.No product was returned for evaluation and no x-rays, scans, pictures, or physician's reports were provided.Device history record (dhr) was reviewed and no discrepancies were found.The surgeon reported several patient conditions that he states could have attributed to the infection.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following sections were updated: date of this report.Date received by manufacturer.Type of report and follow-up number.Follow-up type.Device evaluated by manufacturer and not returned to manufacturer.Method code updated to 3263 - actual device not evaluated, 3317 - manufacturing review, and 3323 - no testing methods performed.Results code updated to 3221 - no results available since no evaluation performed conclusions code updated to 50 - device failure related to patient condition and 92 - device not returned.Additional narratives/data.

• Brand Name: SPF-PLUS 60/M
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 7436129
• MDR Text Key: 105669535
• Report Number: 0002242816-2018-00007
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• PMA/PMN Number: PP850035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

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: Physician
• Device Expiration Date: 06/02/2017
• Device Model Number: N/A
• Device Catalogue Number: 10-1398M
• Device Lot Number: 571-15
• Other Device ID Number: (01) 0 0812301 02012 6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 05/18/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention