MatrixMIDFACE 04.503.206.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10887587018812), received between Jul 16, 2018 and Oct 30, 2024 — classified as 8 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (22 reports).

2 other recalls cover devices cleared under the same FDA submission (K050608, K083388); they may or may not involve this specific model.

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

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE MATRIX MIDFACE SCREW BROKE. IT IS ALSO UNKNOWN IF SURGERY WAS DELAYED, FRAGMENTS WERE GENERATED OR IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567364 ↗
• InjurySep 12, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, TWO MANDIBLE PLATES WERE REMOVED FROM THE PATIENT. THE SCREWS, AND THEREFORE THE PLATES, HAD BECOME LOOSE. SOME OF THE SCREWS HAD BACKED OUT FROM THE MANDIBLE. THE WHOLE CONSTRUCT WAS REMOVED, INCLUDING TWO PLATES AND EIGHT SCREWS. THE PATIENT EXPERIENCED SOME MILD DISCOMFORT AND LOCALIZED SWELLING. WHEN THE PLATES AND SCREWS WERE REMOVED, BICORTICAL SCREWS WERE INSERTED TO FIXATE THE MANDIBLE. THE IMPLANTS HAD BEEN PLACED ON (B)(6) 2023. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. IT IS FELT BY THE SURGEONS THEY ARE LIKELY GETTING AN ELEMENT OF THERMAL NECROSIS IN THE BONE DUE TO THE POWER TOOL (NONE SYNTHES PRODUCT) THEY ARE USING. THIS IS CAUSING THE LOSS OF BONE AND THEREFORE THE SCREWS ARE BACKING OUT. THIS REPORT INVOLVES ONE TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 3 OF 9 FOR (B)(4).

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 17729057 ↗
• InjurySep 12, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, TWO MANDIBLE PLATES WERE REMOVED FROM THE PATIENT. THE SCREWS, AND THEREFORE THE PLATES, HAD BECOME LOOSE. SOME OF THE SCREWS HAD BACKED OUT FROM THE MANDIBLE. THE WHOLE CONSTRUCT WAS REMOVED, INCLUDING TWO PLATES AND EIGHT SCREWS. THE PATIENT EXPERIENCED SOME MILD DISCOMFORT AND LOCALIZED SWELLING. WHEN THE PLATES AND SCREWS WERE REMOVED, BICORTICAL SCREWS WERE INSERTED TO FIXATE THE MANDIBLE. THE IMPLANTS HAD BEEN PLACED ON (B)(6) 2023. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. IT IS FELT BY THE SURGEONS THEY ARE LIKELY GETTING AN ELEMENT OF THERMAL NECROSIS IN THE BONE DUE TO THE POWER TOOL (NONE SYNTHES PRODUCT) THEY ARE USING. THIS IS CAUSING THE LOSS OF BONE AND THEREFORE THE SCREWS ARE BACKING OUT. THIS REPORT INVOLVES ONE TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 17729055 ↗
• InjurySep 12, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, TWO MANDIBLE PLATES WERE REMOVED FROM THE PATIENT. THE SCREWS, AND THEREFORE THE PLATES, HAD BECOME LOOSE. SOME OF THE SCREWS HAD BACKED OUT FROM THE MANDIBLE. THE WHOLE CONSTRUCT WAS REMOVED, INCLUDING TWO PLATES AND EIGHT SCREWS. THE PATIENT EXPERIENCED SOME MILD DISCOMFORT AND LOCALIZED SWELLING. WHEN THE PLATES AND SCREWS WERE REMOVED, BICORTICAL SCREWS WERE INSERTED TO FIXATE THE MANDIBLE. THE IMPLANTS HAD BEEN PLACED ON (B)(6) 2023. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. IT IS FELT BY THE SURGEONS THEY ARE LIKELY GETTING AN ELEMENT OF THERMAL NECROSIS IN THE BONE DUE TO THE POWER TOOL (NONE SYNTHES PRODUCT) THEY ARE USING. THIS IS CAUSING THE LOSS OF BONE AND THEREFORE THE SCREWS ARE BACKING OUT. THIS REPORT INVOLVES ONE TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 17729054 ↗
• InjurySep 12, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, TWO MANDIBLE PLATES WERE REMOVED FROM THE PATIENT. THE SCREWS, AND THEREFORE THE PLATES, HAD BECOME LOOSE. SOME OF THE SCREWS HAD BACKED OUT FROM THE MANDIBLE. THE WHOLE CONSTRUCT WAS REMOVED, INCLUDING TWO PLATES AND EIGHT SCREWS. THE PATIENT EXPERIENCED SOME MILD DISCOMFORT AND LOCALIZED SWELLING. WHEN THE PLATES AND SCREWS WERE REMOVED, BICORTICAL SCREWS WERE INSERTED TO FIXATE THE MANDIBLE. THE IMPLANTS HAD BEEN PLACED ON (B)(6) 2023. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. IT IS FELT BY THE SURGEONS THEY ARE LIKELY GETTING AN ELEMENT OF THERMAL NECROSIS IN THE BONE DUE TO THE POWER TOOL (NONE SYNTHES PRODUCT) THEY ARE USING. THIS IS CAUSING THE LOSS OF BONE AND THEREFORE THE SCREWS ARE BACKING OUT. THIS REPORT INVOLVES ONE TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 17729050 ↗
• InjurySep 12, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, TWO MANDIBLE PLATES WERE REMOVED FROM THE PATIENT. THE SCREWS, AND THEREFORE THE PLATES, HAD BECOME LOOSE. SOME OF THE SCREWS HAD BACKED OUT FROM THE MANDIBLE. THE WHOLE CONSTRUCT WAS REMOVED, INCLUDING TWO PLATES AND EIGHT SCREWS. THE PATIENT EXPERIENCED SOME MILD DISCOMFORT AND LOCALIZED SWELLING. WHEN THE PLATES AND SCREWS WERE REMOVED, BICORTICAL SCREWS WERE INSERTED TO FIXATE THE MANDIBLE. THE IMPLANTS HAD BEEN PLACED ON (B)(6) 2023. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. IT IS FELT BY THE SURGEONS THEY ARE LIKELY GETTING AN ELEMENT OF THERMAL NECROSIS IN THE BONE DUE TO THE POWER TOOL (NONE SYNTHES PRODUCT) THEY ARE USING. THIS IS CAUSING THE LOSS OF BONE AND THEREFORE THE SCREWS ARE BACKING OUT. THIS REPORT INVOLVES ONE TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 17729048 ↗
• InjurySep 12, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, TWO MANDIBLE PLATES WERE REMOVED FROM THE PATIENT. THE SCREWS, AND THEREFORE THE PLATES, HAD BECOME LOOSE. SOME OF THE SCREWS HAD BACKED OUT FROM THE MANDIBLE. THE WHOLE CONSTRUCT WAS REMOVED, INCLUDING TWO PLATES AND EIGHT SCREWS. THE PATIENT EXPERIENCED SOME MILD DISCOMFORT AND LOCALIZED SWELLING. WHEN THE PLATES AND SCREWS WERE REMOVED, BICORTICAL SCREWS WERE INSERTED TO FIXATE THE MANDIBLE. THE IMPLANTS HAD BEEN PLACED ON (B)(6) 2023. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. IT IS FELT BY THE SURGEONS THEY ARE LIKELY GETTING AN ELEMENT OF THERMAL NECROSIS IN THE BONE DUE TO THE POWER TOOL (NONE SYNTHES PRODUCT) THEY ARE USING. THIS IS CAUSING THE LOSS OF BONE AND THEREFORE THE SCREWS ARE BACKING OUT. THIS REPORT INVOLVES ONE TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 17729046 ↗
• InjurySep 12, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, TWO MANDIBLE PLATES WERE REMOVED FROM THE PATIENT. THE SCREWS, AND THEREFORE THE PLATES, HAD BECOME LOOSE. SOME OF THE SCREWS HAD BACKED OUT FROM THE MANDIBLE. THE WHOLE CONSTRUCT WAS REMOVED, INCLUDING TWO PLATES AND EIGHT SCREWS. THE PATIENT EXPERIENCED SOME MILD DISCOMFORT AND LOCALIZED SWELLING. WHEN THE PLATES AND SCREWS WERE REMOVED, BICORTICAL SCREWS WERE INSERTED TO FIXATE THE MANDIBLE. THE IMPLANTS HAD BEEN PLACED ON (B)(6) 2023. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. IT IS FELT BY THE SURGEONS THEY ARE LIKELY GETTING AN ELEMENT OF THERMAL NECROSIS IN THE BONE DUE TO THE POWER TOOL (NONE SYNTHES PRODUCT) THEY ARE USING. THIS IS CAUSING THE LOSS OF BONE AND THEREFORE THE SCREWS ARE BACKING OUT. THIS REPORT INVOLVES ONE TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 17729043 ↗
• InjurySep 1, 2023Migration; Migration

  THIS IS REPORT 1 OF 9 FOR COMPLAINT (B)(4).

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 17669746 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538034 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM URUGUAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538026 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM URUGUAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538022 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM URUGUAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538020 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM URUGUAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538017 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM URUGUAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 3 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538014 ↗
• MalfunctionOct 4, 2022Break; Break

  THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538013 ↗
• MalfunctionOct 4, 2022Break; Break

  THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538010 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM URUGUAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538009 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM URUGUAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537870 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM URUGUAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 3 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537867 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM URUGUAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537859 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537857 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM URUGUAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537853 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM URUGUAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537852 ↗
• MalfunctionOct 4, 2022Break; Break

  DEVICE REPORT FROM URUGUAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE PLACING THE CORTICAL SCREWS IN QUESTION THEY WOULD FRAGMENT AND DISINTEGRATE. WHEN FORCE WAS APPLIED TO THE SCREWS, THEY WOULD BREAK APART WITHOUT PROVIDING ANY RESISTANCE AT ALL. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537851 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050608, K083388. One submission often covers many models, so check the product and lot details in each record.

• Z-2739-2020 · Jun 16, 2020 · Terminated
  MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive proced
• Z-2272-2015 · Jun 24, 2015 · Terminated
  Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixati