MAUDE Adverse Event Report: BIOMET MICROFIXATION CUSTOM MADE DEVICE ELSHEBANI LEFT PM-TMJ & MODEL; CUSTOM MADE TMJ

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: biomet microfixation screws catalog #: ni, lot #: ni.Therapy date: (b)(6) 2019.(b)(6).Pma/510(k) number: this product is not cleared or distributed in the u.S.However, this report is being submitted as biomet microfixation manufactures a similar device that is cleared or distributed in the united states under pma number (b)(4) customer has indicated that the product will not be returned to zimmer biomet for investigation it was implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported in (b)(6): during surgery: in the first phase it has been implanted as intended, but the occlusion did not fit.For that reason the surgeon decided intraoperatively to solve the three fixed screws and to move the both mandibular.Patient matched implant.Approximately 2 mm to the procedure.Condylaris (cranial) above.Theory: the opened, denture of the front teeth has been closed, as the mandible rotate against the clockwise direction.It hasn´t taken into account, that the mandible above the maxilla-molars move and for that reason the ramus extended vertical, and for that reason the new jaw angle is low as at the starting point.During the development is visible that the jaw angle is at the same.Height as previously, which is not possible, due to as result the ramus contracted.The mandibular component has been removed approx.2mm to the fossa direction.The ct scan will be made postoperative.The ct has been done.Postoperative - please compare the pre surgery data with the planning, if this theory is correct.The patient is fine and the occlusion is functioning.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.

Event Description

It was determined that the part information initially provided was incorrect.The investigation that has been completed thus far is invalid as it has been for the wrong part number and patient.For the initial part number provided tmjpm-2329, the sales associated reported that there was no complaint.The correct part number is tmjpm-2347.

Manufacturer Narrative

It was determined that the part information initially provided was incorrect.The investigation that has been completed thus far is invalid as it has been for the wrong part number and patient.For the initial part number provided tmjpm-2329, the sales associate reported that there was no complaint.The correct part number is tmjpm-2347.A new complaint has been created to investigate the correct part number which is captured in cmp-0506055 and mfr# 0001032347-2019-00297.

• Brand Name: CUSTOM MADE DEVICE ELSHEBANI LEFT PM-TMJ & MODEL
• Type of Device: CUSTOM MADE TMJ
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8322055
• MDR Text Key: 135683182
• Report Number: 0001032347-2019-00095
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2023
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-2329
• Device Lot Number: 874730A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention