MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM 2 HOLE LONG STRAIGHT PLATE; BONE PLATE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: biomet microfixation 1.5mm x 3.5mm ht sd x-dr screw catalog #: 91-6103 lot #: ni.Therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00223.

Event Description

It was reported by the patient she had an mri and six days later developed a bleed underneath the plate.She indicated that she was hospitalized for two days in the icu as a result of the bleed, but did not undergo any additional therapy or surgery.She stated her doctors informed her that the bleed may have been due to damage to small vessels.The patient is scheduled to have a ct scan in order to confirm that the bleed is resolved.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 patient had these implants for more than three years, had an mri on (b)(6) 2018, and developed fluid buildup underneath her plate six days later on (b)(6) 2018.However, the patient did not receive any additional therapy or surgery, and a definitive cause could not be determined by her physicians.The implants remain implanted; therefore, functional testing and inspections could not be performed.There was limited information provided and no materials such as photographs, scans, x-rays, or physician's 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.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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00223-1.

• Brand Name: 1.5MM SYSTEM 2 HOLE LONG STRAIGHT PLATE
• Type of Device: BONE PLATE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7475336
• MDR Text Key: 106971882
• Report Number: 0001032347-2018-00222
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Device Model Number: N/A
• Device Catalogue Number: 01-7347
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00841036013899
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization