MAUDE Adverse Event Report: DJO LLC. CMF OL1000 SINGLE COIL SIZE 4; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number	01-211-0004
Medical Device Problem Codes	No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health professional, occupation: unknown.No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Event or Problem Description
It was reported that the device "was too big and is causing headaches, jaw aches, and tooth sensitivity to hot and cold." the patient's physician believes that the use of the bone growth stimulator contributed to the patient's complaint.The device has not been returned to the manufacturer for evaluation.If the device is returned, a follow-up report will be submitted upon completion of device evaluation.
Event or Problem Description
It was reported that the device "was too big and is causing headaches, jawaches, and tooth sensitivity to hot and cold." the patient's physician believes that the use of the bone growth stimulator contributed to the patient's complaint.The device has not been returned to the manufacturer for evaluation.If the device is returned, a follow-up report will be submitted upon completion of device evaluation.
Additional Manufacturer Narrative
D3: manufacturer corrected / updated.H3, h6: device was returned for evaluation.During device evaluation results were observed to be within device specifications.Device performed as expected.Could not duplicate reported event.No failure identified.

• Brand Name: CMF OL1000 SINGLE COIL SIZE 4
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): DJO LLC.; 1430 decision street; vista, ca
• MDR Report Key: 10128119
• Report Number: 3012446970-2020-00020
• Device Sequence Number: 2094672
• Product Code: LOF
• UDI-Device Identifier: 00888912161770
• UDI-Public: 00888912161770
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 01-211-0004
• Device Catalogue Number: 01-211-0004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1