Patient-Fitted TMJ Reconstructive Prosthesis System TYY-NNNNLFRecalls & reported problems
TMJ Solutions, Inc. · Left Fossa Component · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This TMJ Solutions jaw joint implant is a left-side fossa part used to rebuild the jaw joint. Reports mostly describe infections, ongoing pain, and parts that broke, moved out of place or dislocated, often needing removal or replacement surgery. There are 24 reports that name its identifier, with no deaths and 21 injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI B004TYYNNNNLF0), received between Feb 8, 2019 and Aug 26, 2021 — classified as 21 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem19
- Fracture3
- Malposition of Device2
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
- Patient Device Interaction Problem1
- Positioning Problem1
Patient problems
- Unspecified Infection8
- Implant Pain6
- Joint Disorder4
- Failure of Implant3
- Arthralgia2
- Joint Dislocation2
- Pain2
- Ankylosis1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2021Fracture; Fracture
THE PATIENT'S LEFT FOSSA COMPONENT IS FRACTURED.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 12374445 ↗InjuryJul 28, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S RIGHT TMJ DEVICES ARE DISLOCATED.
Patient problems: Joint Dislocation
MAUDE report 12236089 ↗InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S LEFT FOSSA COMPONENT WAS REMOVED AND REPLACED WITH A REVISED COMPONENT DUE TO DISLOCATION.
Patient problems: Fibrosis; Joint Dislocation
MAUDE report 11996703 ↗InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Bacterial Infection; Implant Pain
MAUDE report 11971492 ↗MalfunctionMay 25, 2021Fracture; Fracture
THE SURGEON REPORTED THAT THE PATIENT HAS HAD SEVERE PAIN SINCE IMPLANTATION BILATERALLY. ON CT SCAN, IT APPEARED THE FOSSA COMPONENT HAS FRACTURED.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 11882155 ↗InjuryApr 15, 2021Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem
THE LEFT FOSSA COMPONENT WAS REMOVED DUE TO MALPOSITION.
Patient problems: Pain
MAUDE report 11674297 ↗InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE LEFT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Hematoma; Swelling/ Edema; Unspecified Infection
MAUDE report 11198292 ↗InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON REMOVED THE LEFT TMJ DEVICES DUE TO PAIN.
Patient problems: Arthralgia; Implant Pain
MAUDE report 11158416 ↗InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED DUE TO PAIN.
Patient problems: Arthralgia; Implant Pain
MAUDE report 10833752 ↗InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S LEFT TMJ DEVICES ARE INFECTED, AND PENDING FOR REMOVAL.
Patient problems: Drug Resistant Bacterial Infection; Post Operative Wound Infection
MAUDE report 10709043 ↗MalfunctionOct 7, 2020Fracture; Fracture
THE PATIENT'S LEFT FOSSA COMPONENT WAS REMOVED DUE TO FRACTURED.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 10646363 ↗InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
THE LEFT TMJ DEVICES WERE REMOVED DUE TO MATERIAL SENSITIVITY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 10435115 ↗InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON REMOVED THE HETEROTOPIC BONE FROM THE PATIENT'S LEFT TMJ DEVICES.
Patient problems: Joint Disorder; Pain
MAUDE report 10348160 ↗InjuryJul 28, 2020Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED AND REVISED DUE TO MALPOSITIONING SECONDARY TO FAILED SAGITTAL SPLIT OSTEOTOMY ON THE CONTRALATERAL SIDE.
Patient problems: Joint Disorder
MAUDE report 10335453 ↗InjuryJul 23, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
THE PATIENT'S LEFT FOSSA COMPONENT WAS REMOVED AND REPLACED WITH A REVISION DEVICE BECAUSE OF LOOSE BONE SCREWS.
Patient problems: Joint Disorder
MAUDE report 10317613 ↗InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S BILATERAL TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10311740 ↗InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S LEFT TMJ FOSSA WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10224266 ↗InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10194981 ↗InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10192755 ↗InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED DUE TO MALOCCLUSION AND PAIN.
Patient problems: Joint Disorder
MAUDE report 10173870 ↗InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED DUE TO A SUSPECTED INFECTION.
Patient problems: Extraskeletal ossification; Swelling; Unspecified Infection
MAUDE report 9919035 ↗InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S LEFT FOSSA COMPONENT WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9666728 ↗InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD SURGERY TO REMOVE THE LEFT FOSSA COMPONENT DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 8324335 ↗
Other Joint, Temporomandibular, Implant devices
- Patient-Fitted TMJ Reconstructive Prosthesis System CHG020TMJ Solutions, Inc. · Joint, Temporomandibular, Implant2 recalls172 reports
- Patient-Fitted TMJ Reconstructive Prosthesis System CHG010TMJ Solutions, Inc. · Joint, Temporomandibular, Implant1 recall94 reports
- TMJ SYSTEM 24-6563Biomet Microfixation, Inc · Joint, Temporomandibular, Implant89 reports
- TMJ SYSTEM 24-6562Biomet Microfixation, Inc · Joint, Temporomandibular, Implant76 reports
- Patient-Fitted TMJ Reconstructive Prosthesis System TYY-NNNNMTMJ Solutions, Inc. · Joint, Temporomandibular, Implant65 reports
- Patient-Fitted TMJ Reconstructive Prosthesis System CHG010AMTMJ Solutions, Inc. · Joint, Temporomandibular, Implant1 recall0 reports
- Patient-Fitted TMJ Reconstructive Prosthesis System TYY-NNNNRMTMJ Solutions, Inc. · Joint, Temporomandibular, Implant38 reports
- Patient-Fitted TMJ Reconstructive Prosthesis System TYY-NNNNLMTMJ Solutions, Inc. · Joint, Temporomandibular, Implant31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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