MAUDE Adverse Event Report: OSTEOMED, LLC UNKNOWN

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Difficulty Chewing (4522)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

On 03aug2020 osteomed was notified that, "the plate fractured had to be removed and it was replaced by other osteomed plate.The patient is healthy and well." on 05aug2020 the quality analyst at (b)(4) (osteomed distributor) notifies that they received a quality deviation notification from one of their distributors describing: "the patient reported to the surgeon that he was feeling something strange and thought he was feeling the loose jaw, it was found that there was a broken plaque and the rest were loose".However, several attempts were made to get additional information from the customer (product information, health impact) without any success.Therefore, root cause could not be established for the customer complaint.Complaints will continue to be monitored and trended.Per the limited information received from the customer and no product information, the root cause is undetermined.Complaints will continue to be monitored and trended.

Event Description

On 03aug2020 the sales manager notified that, "the plate fractured had to be removed and it was replaced by other osteomed plate.The patient is healthy and well." on 05aug2020 the quality analyst at (b)(4) (osteomed distributor) notifies that they received a quality deviation notification from one of their distributors describing: "the patient reported to the surgeon that he was feeling something strange and thought he was feeling the loose jaw, it was found that there was a broken plate and the rest were loose".After several communication attempts the customer has not provided the patient information, product and/or product information (part number and lot number) to conduct an investigation.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho road; addison TX 75001
• MDR Report Key: 12652618
• MDR Text Key: 281344340
• Report Number: 2027754-2021-00017
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1