MAUDE Adverse Event Report: BIOMET MICROFIXATION "2.7MM" SYSTEM EMERGENCY CROSS DRIVE SCREW 1/PKG; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Sleep Dysfunction (2517); Difficulty Chewing (2670)

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.The device will not be returned for evaluation as it remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00444, 0001032347-2019-00445, 0001032347-2019-00446, 0001032347-2019-00447, 0001032347-2019-00448, 0001032347-2019-00449, 0001032347-2019-00450, 0001032347-2019-00451, 0001032347-2019-00452, 0001032347-2019-00453.Concomitant medical products: tmj system left fossa component small, cat# 24-6563, lot# 761290a; tmj system right fossa component small, cat# 24-6562, lot# 783330b; tmj system left standard mandibular component, cat# 24-6551, lot# 751050c; tmj system right standard mandibular component, cat# 24-6550, lot# 759080a; "2.4mm" system high torque (ht) cross-drive screw, cat# 91-2708, lot# unk; "2.44mm" system high torque (ht) cross-drive screw, cat# 91-2710, lot# unk; traumaone system 2.0x7mm self-drilling imf screw, cat# 91-5607, lot# unk; traumaone system 2.0x9mm self-drilling imf screw, cat# 91-5609, lot# unk; tmj system cross drive fossa screw, cat# 99-6577, lot# unk; tmj system cross drive emergency fossa screw, cat# 99-6587, lot# unk; "2.7mm" system emergency cross drive screw 1/pkg, cat# 99-9948, lot# unk.Occupation: patient.

Event Description

It was reported the patient underwent a medical intervention to treat pain associated with their temporomandibular implants.The patient has facial pain that causes difficulty eating and sleeping.The patient has received botox injections and is currently prescribed lyrica, amitriptyline, and tramadol to treat pain and sleeplessness associated with pain.No additional patient consequences have been 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.The complaint is non-verifiable.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 dhrs for the screws involved in this case could not be reviewed due to the lot numbers being unknown.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.

• Brand Name: "2.7MM" SYSTEM EMERGENCY CROSS DRIVE SCREW 1/PKG
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9177343
• MDR Text Key: 173162705
• Report Number: 0001032347-2019-00454
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00841036058555
• UDI-Public: 00841036058555
• Combination Product (y/n): N
• PMA/PMN Number: K113512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

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: 99-9948
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention