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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: (b)(6) 2021.Medical product: unknown.Therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported by the sales rep that a month following implantation of bone stimulator, pt had infection which required i&d.Surgeon commented bone stimulator had majority of puss around it, but unaware of it caused infection.

• Brand Name: OSTEOGEN-20/M
• Type of Device: STIMULATOR, IMPLANTABLE
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: tanisha tucker ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 11831139
• MDR Text Key: 250868943
• Report Number: 0002242816-2021-00066
• Device Sequence Number: 1
• Product Code: LOE
• UDI-Device Identifier: 00812301020034
• UDI-Public: 00812301020034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790005/S044
• 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
• Report Date: 05/17/2021

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: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention