MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW (2.0MM X 9MM); BONE SCREW

Model Number N/A

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

Patient Problems Muscle Spasm(s) (1966); Swelling (2091); Difficulty Chewing (2670)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).Concomitant medical products: biomet microfixation tmj right standard mandibular component, small catalog #: 24-6546 lot #: 370980a, biomet microfixation tmj left fossa component, small catalog #: 24-6563 lot #: 356440b, biomet microfixation 2.7mm emergency cross drive screw catalog #: 99-9950 lot #: ni, biomet microfixation 2.0x10mm cross-drive screw catalog #: 41-2010 lot #: ni, biomet microfixation 2.4mm system high torque cross drive screw catalog #: 91-2710 lot #: ni.Limited mobility of the implanted joint.Customer has indicated that the product will not be returned to zimmer biomet for investigation, the device 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 reports: 0001032347-2018-00172 through 0001032347-2018-00177.

Event Description

It was reported by the patient she has difficulty chewing, difficulty opening mouth, facial swelling, and muscle spasms.She reports her physician prescribed medicine for the muscle spasms.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 parts remain implanted, therefore functional testing and inspections could not be made due to the products not being returned.No additional materials in the form of photographs, scans, x-rays, physician's reports have been 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 reports: 0001032347-2018-00172-1, 0001032347-2018-00173-1, 0001032347-2018-00174-1, 0001032347-2018-00175-1, and 0001032347-2018-00177-1.

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW (2.0MM X 9MM)
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7393875
• MDR Text Key: 104249257
• Report Number: 0001032347-2018-00176
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: PK910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• 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: 99-6579
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00841036057459
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention