MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN SPORTS MEDICINE; FASTENER, FIXATION

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problems Dyspnea (1816); Pain (1994)

Event Type  Injury  

Event Description

It was reported that patient underwent a right temporomandibular joint (tmj) procedure on (b)(6) 2014 to anchor the disc to the bone with a bone anchor.Subsequently, the disc loosened.Patient alleges currently experiencing difficulty moving jaw, shortness of breath and pain.No revision procedure has been reported to date.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.[maude report mw5040874].

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

Event Description

It was reported that patient underwent a right temporomandibular joint (tmj) procedure on (b)(6) 2014 to anchor the disc to the bone with a bone anchor.Subsequently, the disc loosened.Patient alleges that the anchor is severed and is currently experiencing difficulty moving jaw, shortness of breath and pain.No revision procedure has been reported to date.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

• Brand Name: UNKNOWN SPORTS MEDICINE
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4880180
• MDR Text Key: 6062128
• Report Number: 0001825034-2015-02705
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/09/2015

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• 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: 07/09/2015
• Initial Date FDA Received: 06/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2015
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR