MAUDE Adverse Event Report: BIOMET MICROFIXATION "2,4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW; PLATE, BONE

Model Number N/A

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

Patient Problem Cancer (3262)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00440, 0001032347-2019-00441, 0001032347-2019-00443.Concomitant medical products: tmj system left fossa component, small, cat# 24-6563, lot# 166460a; tmj system left standard mandibular component, cat# 24-6556, lot# 831890b; "2,4mm" system high torque (ht) cross-drive screw, cat# 91-2710, lot# unk; tmj system cross drive fossa screw, cat# 99-6577, lot# unk.Occupation: patient.

Event Description

It was reported a patient underwent a revision to remove temporomandibular implants on the left side.The implant was removed due to squamous cell carcinoma in the oral cavity.Attempts have been made but no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.No product was returned; therefore, no functional tests or inspections could be performed.An x-ray was received, however, the x-ray showed a right mandible plate which spanned a gap between the patient's ramus and chin, and was fractured at the chin.Five follow up attempts were made for additional information regarding this implant's identity and scans relating to the left mandible and left fossa components in this complaint file.Tmj tracking confirmed that a left mandible (part# 24-6556, lot# 831890b), left fossa (part# 24-6563, lot# 166460a) and screws (part# 91-2710, 99-6577) were implanted on (b)(6) 2010.The provided x-ray was taken on (b)(6) 2019, prior to removal of the right mandible plate, and a nurse from the hospital confirmed that the right mandible was removed (b)(6) 2019.The x-ray was reviewed by the clinical research team, who concluded there was no evidence indicating that a tmj replacement surgery ever occurred on either side of the patient in the images.The most likely underlying cause cannot be determined.There are no additional 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: "2,4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9175341
• MDR Text Key: 168608355
• Report Number: 0001032347-2019-00442
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036053642
• UDI-Public: 00841036053642
• Combination Product (y/n): N
• PMA/PMN Number: K001238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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: 91-2710
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention