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

Model Number N/A

Device Problem Biocompatibility (2886)

Patient Problem Tissue Damage (2104)

Event Date 12/22/2017

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Medical product: unknown screw.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 loss of gingiva between teeth #6/7 and teeth #9/10 was identified.The device was removed but not due to any complication.There was no medical intervention for the retraction.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.The product identities were not confirmed due to the product not being returned.No product was returned and no functional tests or inspections could be performed.No scans, pictures, or physicians reports were provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.There are no indications of manufacturing defects.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: tissue necrosis due to compression on the gingiva.Inadequate healing.Injury or damage to teeth or periodontal structures.The ifu also states in the section titled precautions: "the ends of the arch bars may need to be contoured with the adjustment tool toward the tissue to reduce the probability of tissue irritation", "sharp edges should be smoothed to avoid soft tissue damage or irritation", and "placement sites of screws should be chosen to avoid tooth roots and compression of the tissue by the arch bar." 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.(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
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 7334786
• MDR Text Key: 102246554
• Report Number: 0001032347-2018-00127
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK143336
• 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,Followup
• Report Date: 08/16/2018

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR