MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN TMJ IMPLANT

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The user facility is foreign; therefore a facility medwatch report will not be available.The product remains implanted in the patient and therefore will not be returned for an evaluation.Because the part and lot numbers are unknown, the device history records could not be pulled and reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.The reason for the late report is due to human error.

Event Description

It was reported that a patient complained of pain in the auricular area post temporomandibular joint reconstruction with a stock implant system.It is reported that in the surgeon's opinion the implant is not dislocated, but it appears that the mandibular component has migrated posteriorly from its original placement and the condylar head of the mandible component is causing pressure against the ear canal, triggering the pain experienced by the patient.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

(in addition to what was already reported) the patient's revision surgery was scheduled to take place on wed, (b)(6) 2016 to re-align the mandibular component.

Manufacturer Narrative

The implants were re-implanted in the patient and the old screws were discarded; therefore they will not be returned for evaluation.Because the products were not returned, the product identity could not be confirmed and the most-likely cause could not be determined.The instructions for use warn of potential for complications and it warns against re-using the implants.

Event Description

(in addition to what was already reported) additional information was provided on nov 29, 2016.It was reported that during the revision surgery, the implants were removed, wiped down within the operative field, and then re-implanted.It is reported that new screws were used and the old screws were discarded.

• Brand Name: UNKNOWN TMJ IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6060575
• MDR Text Key: 58849406
• Report Number: 0001032347-2016-00618
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN TMJ IMPLANT
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/04/2016; 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention