MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM OMNIMAX ARCH BAR

Model Number N/A

Device Problem Biocompatibility (2886)

Patient Problem Host-Tissue Reaction (1297)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: unknown screws.Therapy date: (b)(6) 2017.Customer has indicated that the product will not be returned to zimmer biomet for investigation, they were discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported in a clinical study during the scheduled removal of the system, a stab incision had to be made to remove two screws due to mucosal overgrowth; left posterior and left anterior mandibular screws.The system was not removed due to a complication.There was satisfactory occlusion during the entire period of mmf, no adjustments to the device.No gingival necrosis.The severity is indicated as mild.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned and no functional tests or inspections could be performed.No pictures were provided.For these reasons, the complaint could not be verified and the most likely underlying cause of the complaint could not be determined.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The instructions for use (ifu) for this product states in the section titled possible adverse effects: increased fibrous tissue response around the implant.It also states in the section titled directions for use: "the surgeon should confirm that final placement of screw and arch bar does not compress the gingival soft tissue ".If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Unique identifier (udi) #: (b)(4).

• Brand Name: TRAUMAONE SYSTEM OMNIMAX ARCH BAR
• Type of Device: ARCH BAR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7335878
• MDR Text Key: 102309674
• Report Number: 0001032347-2018-00128
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: PK143336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: N/A
• Device Catalogue Number: 01-0298
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR