MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 9MM; PLATE, BONE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).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: 0001032347-2020-00463, 0001032347-2020-00464, 0001032347-2020-00465, 0001032347-2020-00466, 0001032347-2020-00467, 0001032347-2020-00468, 0001032347-2020-00469.Medical products: tmj system right narrow mandibular component 45mm / 6 hole, part# 01-6545, lot# 065120; tmj system left narrow mandibular component 45 mm / 6 hole, part# 01-6546, lot# 065150; tmj system right fossa component, small, part# 24-6562, lot# 148990; tmj system left fossa component, small, part# 24-6563, lot# 123890; 2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# ni; 2.4mm system high torque (ht) cross-drive screw 2.7mm x 12mm, part# 91-2712, lot# ni; tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni; tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# ni.Occupation ¿ patient.

Event Description

It was reported that the patient is experiencing pain and limited range of motion fourteen (14) years following implantation of bilateral temporomandibular joint implants.The patient believes the implant has dislocated and is seeing a surgeon for a nerve related issue.There is no revision planned at this time.It was reported that no further information is available.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided for the screws.A definitive root cause cannot be determined.If any further information 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

No further event information available at the time of this report.

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 9MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10590421
• MDR Text Key: 208774186
• Report Number: 0001032347-2020-00470
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 99-6579
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention