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

Model Number N/A

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

Patient Problems Headache (1880); Itching Sensation (1943); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: biomet microfixation tmj right fossa component, small catalog #: 24-6562 lot #: 503450a, biomet microfixation tmj right standard mandibular component catalog #: 24-6545 lot #: 535280a, biomet microfixation tmj left standard mandibular component catalog #: 24-6546 lot #: 567720a, biomet microfixation tmj left fossa component, small catalog #: 24-6563 lot #: 501530a, 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 devices remain implanted.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: 000103347-2018-00158, 000103347-2018-00159, 000103347-2018-00160, 000103347-2018-00161, and 000103347-2018-00162.

Event Description

It was reported the patient is having pain, inability to open her mouth, and difficulty eating.The patient advises she's had the symptoms since the surgery.She states she is having migraine attacks for which she is not taking any medication or receiving any treatment.Her surgeon and primary doctors state the pain is normal and she can consult a migraine doctor for a second opinion.She adds the area around the implant itches (she is not using any cream or medication for this) and she feels a "bump" where the implants are and thinks this means the joints are out of place.She has not had ct scans or x-rays to confirm this.Concerning her mouth opening and eating issues, she was instructed by the surgeon to do open/ close movement exercises to improve the opening.She says she currently has to use her fingers because she cannot open her mouth wide enough for a utensil.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 has not had ct scans, x-rays, photographs, allergy testing to substantiate her complaints.She has not had any reported medical intervention/revision for her complaints.As the patient has not undergone allergy testing in spite of seeing her physicians, this indicates the itching may be related to nerve dysfunction.The bump she feels indicates her implants have become palpable.The implants remain implanted and are not available for visual evaluation or functional testing.The manufacture history for the part and lot number combinations for the tmj implants were reviewed and no discrepancies relevant to the reported event were found.The device history records (dhr) review of the screws was unable to be performed as the lot numbers are unknown.There are no indications of manufacturing defects.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Her complaint regarding migraines is likely a preexisting condition.The instructions for use (ifu) for this product has the following information in the section titled adverse events: loosening or displacement with or without removal of the implant.Infection (systemic or superficial).Foreign body or allergic reaction to implant components.Facial swelling and/or pain.Facial nerve dysfunction.Heterotopic bone formation.Dislocation.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: 000103347-2018-00158-1, 000103347-2018-00159-1, 000103347-2018-00160-1, 000103347-2018-00161-1, and 000103347-2018-00162-1.

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7387253
• MDR Text Key: 104026874
• Report Number: 0001032347-2018-00163
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• 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: 99-6577
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00841036057442
• 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