MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; STIMULATOR, BONE HEALING SYSTEM, NONIVASIVE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: (b)(6) 2021.Concomitant 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 to please switch out the patient's unit to opak.Attached is the new script as well as office note from the physician requesting the switch.The patient is having trouble with the coil and it's causing her discomfort.A new orthopak assembly was shipped to the patient on 2/12.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Type of Device: STIMULATOR, BONE HEALING SYSTEM, NONIVASIVE
• 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: 11728287
• MDR Text Key: 247580181
• Report Number: 0002242816-2021-00049
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020560
• UDI-Public: 00812301020560
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790002
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• 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: 1068234
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2021
• 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