MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICROFIXATION OMNIMAX MMF SYSTEM; SCREW, FIXATION, INTRAOSSEOUS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: biomet microfixation traumaone system omnimax arch bar catalog #: 01-0298; lot #: ni.Therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 that one screw was loose on the upper arch bar (right anterior maxilla).This screw was removed.The surgeon reported the patient is doing well otherwise and this should have no effect on healing.No additional patient consequences were reported.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

There was a revision to remove the loosened screw during a clinical study, therefore the complaint is considered confirmed.Functional testing and inspections could not be performed due to the part not being returned.More than three attempts were made for additional information and materials such as photographs, scans, x-rays, and/or physician's reports, however no new information was yielded.Device history record (dhr) review was unable to be performed as the part number and 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.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.

• Brand Name: BIOMET MICROFIXATION OMNIMAX MMF SYSTEM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7646164
• MDR Text Key: 112601905
• Report Number: 0001032347-2018-00406
• Device Sequence Number: 1
• Product Code: DZL
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR