MAUDE Adverse Event Report: OSTEOMED MEDIUM 6 HOLE BSSO PLATE

Catalog Number 214-0100

Device Problem Break (1069)

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

Event Date 07/15/2016

Event Type  Injury  

Manufacturer Narrative

The root cause for the broken mini, 6 hole, medium bsso plate, p/n 214-0100, is undetermined.The bsso plate broke and was explanted only 10 days after implantation.The plate is expected to be used for 3 months until osteogenesis occurs in the mandible beneath the plate.The examination of the plate shows that the plate was bent both up and down, as well as left to right directions.The bending was done in an effort to conform the plate to the geometry of the mandible section it was being attached to.Per the ifu, multiple bending may weaken the plate and could result in implant fracture and failure.The ifu also states that screw selection is important to consider, based upon bone quality, bone type functional loads exerted on the bone(s), and post-operative patient compliance.Since the bsso plate broke within 10 days of the surgery, osteogenesis would not have occurred.The post-operative instructions given to the patient are unknown.The bone quality of the patient is unknown.However, for the plate to break, a force was applied sometime after surgery, and before the follow-up procedure.Though the exact root cause of the break is unknown, possible causes could be due to a weakened plate, incorrect screw selection, along with post-surgery patient activity.The review of the dhr did not identify any non-conformances with lot release.The review of capas and ncrs did not identify any internal non-conformances for this device.The review of the complaint history shows that this is the first complaint ever received for this device.Per the m3/m4 risk management file, this issues has an overall risk level scroe of low.This issue will be monitored through routine trending.Qa note: during an audit of mdr submissions, we identified that there was an error on the initial submission and follow-up reports that prevented upload to maude.Therefore, this report is being re-submitted.Date of original submission report: 01/25/2017.Date of follow-up report submission: 03/23/2017.

Event Description

On (b)(6) 2017, osteomed received notification of an incident concerning the medium 6 hole bsso plate (p/n 214-0100).A few days after the orthognathic surgery, the bsso plate was broken.

• Brand Name: MEDIUM 6 HOLE BSSO PLATE
• Type of Device: MEDIUM 6 HOLE BSSO 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: 7186393
• MDR Text Key: 97133068
• Report Number: 2027754-2017-00001
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 0845694003728
• UDI-Public: (01)0845694003728(10)1078298(30)1(11)140910
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K911936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/12/2017

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: Physician
• Device Catalogue Number: 214-0100
• Device Lot Number: 1078298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• 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): Required Intervention
• Patient Age: 47 YR