MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT; LEFT MANDIBULAR COMPONENT

Model Number TYY-NNNLM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ankylosis (4527)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

The surgeon released the ankylosis and reported that the implants appeared stable and secure.

Event Description

The surgeon removed the heterotopic bone formation on the left side.

• Brand Name: PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT
• Type of Device: LEFT MANDIBULAR COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura 93003 7607
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 6059 king drive; ventura 93003 7606
• Manufacturer Contact: lorena lundeen ; 6059 king drive; ventura 93003-7607 ; 8056503391
• MDR Report Key: 11052381
• MDR Text Key: 223123660
• Report Number: 2031049-2020-00107
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNLM0
• UDI-Public: +B004TYYNNNNLM0/$$3100101W13165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2020

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: Health Professional
• Device Expiration Date: 01/01/2010
• Device Model Number: TYY-NNNLM
• Device Catalogue Number: TYY-NNNLM
• Device Lot Number: WW13165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR