MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE EMERGENCY FOSSA SCREW 2.3 X 7 MM; PLATE, BONE

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).(b)(4).Concomitant medical products: biomet microfixation tmj system cross drive fossa screw 2.0 x 7 mm, catalog #: 99-6577, lot #: 372440; biomet microfixation 2.4 mm system high torque (ht) cross drive screw 2.7 x 8 mm, catalog #: 91-2708, lot #: 015140; biomet microfixation 2.4 mm system high torque (ht) cross drive screw 2.7 x 8 mm, catalog #: 91-2708, lot #: 429190; biomet microfixation tmj system right standard mandibular component 45 mm/ 7 hole, catalog #: 24-6545, lot #: 442320a; biomet microfixation tmj system right fossa component small, catalog #: 24-6562, lot #: 505150b; biomet microfixation tmj system left standard mandibular component 45 mm/ 7 hole, catalog #: 24-6546, lot #: 488250b; biomet microfixation tmj system left fossa component small, catalog #: 24-6563, lot #: 501510b.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation per hospital policy.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: 0001032347-2018-00844 through 0001032347-2018-00851.

Event Description

It was reported the implants will be removed because they were implanted in the wrong position.No additional patient consequences were 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.Reported event was confirmed by review of design input forms.Functional testing and inspections could not be performed due to the parts not being returned.Per the design input form, there were plans to remove stock prostheses and replace them with a custom implant, indicating the allegation made against the stock tmj implant is confirmed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00844-1, 0001032347-2018-00846-1, 0001032347-2018-00847-1, 0001032347-2018-00848-1, 0001032347-2018-00849-1, 0001032347-2018-00850-1, 0001032347-2018-00851-1.

• Brand Name: TMJ SYSTEM CROSS DRIVE EMERGENCY FOSSA SCREW 2.3 X 7 MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8157773
• MDR Text Key: 130171980
• Report Number: 0001032347-2018-00845
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• 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: 99-6587
• Device Lot Number: 626840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention