MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.4 MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7 X 8 MM; SCREW, FIXATION, BONE

Model Number N/A

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet microfixation tmj system left narrow mandibular component, catalog #: 01-6551, lot #: 541890a.Therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001032347-2018-00872.

Event Description

It was reported a revision was performed due to an allergic reaction.It was confirmed that the mandibular component was removed and replaced with a titanium implant.The surgeon elected to leave the existing fossa in place and used the same screws that were originally implanted in the mandible with the new mandible.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by evidence that the revision surgery was performed.The standard mandible component was replaced with a titanium implant.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to the patient's condition of allergic reaction.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.Date explanted - the distributor stated the surgeon elected to leave the existing fossa in place and used the same screws that were originally implanted in the mandible with the new mandible ((b)(6) 2018).

Event Description

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

• Brand Name: 2.4 MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7 X 8 MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8173787
• MDR Text Key: 130646888
• Report Number: 0001032347-2018-00873
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K113512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

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: 91-2708
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 04/22/2019
• 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
• Patient Age: 41 YR