Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
FDA adverse event reports and recall history for material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction (product code KKY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 215
- Deaths
- 2
- Injuries
- 153
- Malfunctions
- 46
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2017-02-28TerminatedOther
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Mislabeling. The packaging labeled as left mandible contained a right mandible.
- 2014-02-12TerminatedLabeling Change Control
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
- 2008-12-18TerminatedProcess control
Stryker Custom Cranial Implant Kit, small. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00101. Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
Lack of assurance of sterility.
- 2008-12-18TerminatedProcess control
Stryker Custom Cranial Implant Kit, medium. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00102. Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
Lack of assurance of sterility.
- 2008-12-18TerminatedProcess control
Stryker Custom Cranial Implant Kit, large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00103. Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
Lack of assurance of sterility.
- 2008-12-18TerminatedProcess control
Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00104. Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
Lack of assurance of sterility.
- TerminatedEmployee error
OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.
Product mislabeling.
- TerminatedEmployee error
OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.
Product mislabeling.
- TerminatedPackaging
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
Potential sterility deficiency.
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