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

Model Number N/A

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

Patient Problems Nerve Damage (1979); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).The product will not be returned to zimmer biomet for investigation because it remains 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: 0001032347-2019-00378, 0001032347-2019-00379, 0001032347-2019-00380, 0001032347-2019-00381, 0001032347-2019-00382, 0001032347-2019-00383.Concomitant medical products: tmj system right narrow mandibular component, cat# 01-654,5 lot# 710730a; tmj system left narrow mandibular component, cat# 01-6546, lot# 541380d; tmj system right fossa component small, cat# 24-6562, lot# 721350a; tmj system left fossa component small, cat# 24-6563, lot# 721500a; "2.4mm" system high torque (ht) cross-drive screw, cat# 91-2708, lot# unk; "2.4mm" system high torque (ht) cross-drive screw, cat# 91-2710, lot# unk; tmj system cross drive fossa screw, cat# 99-6579, lot# unk.

Event Description

It was reported the patient experienced nerve damage and numbness after implantation of temporomandibular joint implants.The patient described numbness on the right bottom of their jaw and loss of facial expression.The patient said they are only recently able to close their eyes.The patient currently receives botox injections into their forehead to help treat the issues associated with the nerve damage.The patient reported their surgeon stated that the condition is likely permanent.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint was opened because the patient reports numbness and nerve damage resulting from tmj implants.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 complaint is non-verifiable.The dhr's and non-conformance database could not be reviewed for the screws in this case due to the lot numbers being unknown.There are no indications of manufacturing defects.There was no indication that the screws involved in this case contributed to the reported failure mode.The complaints histories were not reviewed for these components.The most likely underlying cause cannot be determined.There are no indications of manufacturing defects.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.

Event Description

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

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8867884
• MDR Text Key: 153528324
• Report Number: 0001032347-2019-00384
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036057459
• UDI-Public: 00841036057459
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 99-6579
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability