MAUDE Adverse Event Report: EBI, LLC. EBI OSTEOGEN-20/M BONE GROWTH STIMULATORS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Device has not been returned.

Event Description

It was reported that the patient experienced pain with the osteogen device.The patient is suffering from a degenerative bone disease and had the device implanted on (b)(6) 2017 as part of an ankle reconstruction.The patient claims to have been in pain since the surgery.Her doctor was running a test for infection, with a scheduled follow up appointment in the coming weeks.No known adverse event was reported.No additional patient consequences were reported.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).This follow-up report is being submitted to relay additional information.The device was not returned for an evaluation as it is still implanted in the patient.The reported event was unable to be confirmed due to limited information from the customer.The device history record (dhr) was reviewed and no discrepancies were found.The root cause was unable to 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.Zimmer biomet will continue to monitor for trends.The following sections were updated: patient code updated to 1994: pain.Device code updated to 3190: insufficient information.Method code updated to 4114: device not returned.Method code updated to 3331: analysis of production records.Results code updated to 3221: no findings available.Conclusions code updated to 4315: cause not established.The following sections were corrected: outcomes attributed to adverse event updated initial reporter also sent the report to fda? updated to unknown.

Event Description

It was reported that the patient experienced pain with the osteogen device.The patient is suffering from a degenerative bone disease and had the device implanted as part of an ankle reconstruction.The patient claims to have been in pain since the surgery.The patient is trying to get the device explanted by their doctor.The patient does not take any pain medication but she does go to pain management.No additional patient consequences were reported.

• Brand Name: EBI OSTEOGEN-20/M BONE GROWTH STIMULATORS
• Type of Device: OSTEOGEN-20/M
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 8112196
• MDR Text Key: 128652070
• Report Number: 0002242816-2018-00037
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• PMA/PMN Number: P790005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/19/2018
• Device Model Number: N/A
• Device Catalogue Number: 10-1320M
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0286-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention