MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE EMERGENCY FOSSA SCREW, 2.3 X 7 MM; SCREW, BONE

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems Nerve Damage (1979); Numbness (2415); Difficulty Chewing (2670)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical device: biomet microfixation tmj system right narrow titanium mandibular component, 45 mm, catalog #: 01-6545ti, lot #: 817540a; biomet microfixation tmj system left standard titanium mandibular component, 45 mm, catalog #: 24-6546ti, lot #: 721710; biomet microfixation tmj system right fossa component, small, catalog #: 24-6562, lot #: 797600; biomet microfixation tmj system left fossa component, small, catalog #: 24-6563, lot #: 795320; biomet microfixation 2.4 mm system high torque (ht) cross-drive screw, catalog #: 91-2708, lot #: ni; biomet microfixation ttmj system cross drive fossa screw, catalog #: 99-6577,, lot #: ni; biomet microfixation 2.7 mm system emergency cross drive screw, 1 pkg, catalog #: 99-9948, lot #: ni; biomet microfixation 2.7 mm system emergency cross drive screw 1/ pkg, catalog #: 99-9950, lot #: ni; therapy date: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation as 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 reports: 0001032347-2019-00078 through 0001032347-2019-00086.

Event Description

It was reported by the patient that the patient is experiencing nerve damage on the right side that her surgeon said would go away but it hasn't.She is also experiencing misalignment of her teeth which makes it difficult for her to chew food like steak, numbness from the middle of the bottom lip to her right ear, and squeaking.Her surgeon informed her that her issues are likely due to her small anatomy.The patient did not receive any intervention for her symptoms.No additional patient consequences were reported.

Event Description

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

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.No product was returned, therefore no functional tests or inspections could be performed.No x-rays, scans, pictures, 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.For these reasons, the 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00078-1, 0001032347-2019-00079-1, 0001032347-2019-00080-1, 0001032347-2019-00081-1, 0001032347-2019-00082-1, 0001032347-2019-00083-1, 0001032347-2019-00085-1, 0001032347-2019-00086-1.

• Brand Name: TMJ SYSTEM CROSS DRIVE EMERGENCY FOSSA SCREW, 2.3 X 7 MM
• Type of Device: SCREW, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8312511
• MDR Text Key: 135229334
• Report Number: 0001032347-2019-00084
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• 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: 99-6587
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other