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

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Skin Irritation (2076); Reaction (2414)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a revision was performed to remove the device due to irritation, pain, and inflammatory response."the patient could feel device through skin causing pain." no additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned and no x-rays, scans, pictures, or physician's reports were provided.Device history record (dhr) was reviewed and no discrepancies 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OSTEOGEN-20/M
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 7374915
• MDR Text Key: 103603342
• Report Number: 0002242816-2018-00006
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

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: 07/27/2018
• Device Model Number: N/A
• Device Catalogue Number: 10-1320M
• Device Lot Number: N/A
• Other Device ID Number: (01)0 0812301 02003 4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention