MAUDE Adverse Event Report: OSTEOMED OSTEOMED SBF SYSTEM; 10 HOLE STRAIGHT PLATE

Catalog Number 210-0032

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2017

Event Type  malfunction  

Event Description

On (b)(4) 2017, osteomed was notified that the plates broke after a meal.

Manufacturer Narrative

The exact root cause for the broken 10-hole straight plate, p/n 210-0032, could not be determined.However, based upon this investigation, it appears to be related to the fact that osteogenesis did not occur in the first 5 months post-surgery.This plate is designed for temporary bone fixation, approximately 7-8 weeks, until osteogenesis (bone growth fixating the bone) occurs.This lack of bone growth placed an extended stress upon the plate for months beyond expectations.Another contributor of this issue is related to the fact that the plate experienced an excessive, short term, abnormal functional stress involving a jaw-clenching incident, which immediately caused the plate to break into multiple pieces.This is considered a non-compliant patient event, even though the incident was not intended, but was admitted to by the patient.The lot number was not provided.Therefore, a review of the dhr could not be performed.A two-year review of capas, ncrs, and complaints did not identify any internal investigations or non-conformances for this device.A review of the labeling, the cfx ifu, warned the user that the plates are intended for temporary fixation until osteogenesis occurs, which did not occur in this instance.The labeling also warned the user about excessive abnormal functional stresses, which the plate experienced.The risk level associated with this incident is low.This issue will be monitored through routine trending.

Event Description

On (b)(6) 2017, osteomed was notified that the plates broke after a meal.

• Brand Name: OSTEOMED SBF SYSTEM
• Type of Device: 10 HOLE STRAIGHT PLATE
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• Manufacturer (Section G): OSTEOMED; 3885 arapaho road; addison TX 75001
• Manufacturer Contact: latoia phillips ; 3885 arapaho road; addison, TX 75001
• MDR Report Key: 6956763
• MDR Text Key: 90532951
• Report Number: 2027754-2017-00010
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K911936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 210-0032
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR