MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW; SCREW, BONE

Model Number N/A

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: biomet microfixation tmj system right fossa component, small, catalog #: 24-6562, lot #: 789880a; biomet microfixation tmj system right narrorw titanium mandibular component, 45 mm, catalog #: 01-6545ti, lot #: 651510d; biomet microfixation 2.4 mm system high torque (ht) cross drive screw, 2.7 x 8 mm, catalog #: 91-2708, lot #: ni; biomet microfixation tmj system cross drive emergency fossa screw, 2.3 x 7 mm, catalog #: 99-6587, lot #: ni.Concomitant medical products: 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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00889 through 0001032347-2018-00892.

Event Description

It was reported a revision was performed due to a possible infection or possible allergic reaction.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

Event Description

This follow-up report is being submitted to relay additional and corrected information.It was reported that a revision was performed due to an allergic reaction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The reported event is considered confirmed as a revision was reported.No product was returned, therefore no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The instructions for use (ifu) for this product states in the section titled 'contraindications': 6.Known allergic reaction to any materials used in the components.It also states in the section titled 'adverse events': ¿ foreign body or allergic reaction to implant components it also states in the section titled 'patient counseling information': discussion of the following points is recommended prior to surgery.¿ the importance of prompt medical attention if they experience unusual swelling in the area of the implant.¿ the risks associated with a total tmj system (see warnings and adverse events).Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to patient's condition.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW
• Type of Device: SCREW, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8199780
• MDR Text Key: 131512710
• Report Number: 0001032347-2018-00893
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K910038
• 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: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 99-6577
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention