Matrix 04.511.225.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10887587023618), received between May 24, 2019 and Sep 29, 2026 — classified as 60 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (21 reports).

1 other recall cover devices cleared under the same FDA submission (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 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Manufacturing, Packaging or Shipping Problem

  It was reported that the customer received an empty screw package. The package was discarded. There was no reported patient or user harm. There was no significant delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933158 ↗
• MalfunctionJan 29, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING AN ORTHOGNATHIC PROCEDURE, AFTER DRILLING WITH DRILL, THE SCREW OVER INSERTED INTO THE PLATE AND PASSED THROUGH THE PLATE. THE SURGEON WANTED TO TRY A NEW PLATE AND RE USED THE SCREW AND IT HAPPENED AGAIN. USED DIFFERENT PLATES AND SCREWS AND IT WORKED AS EXPECTED. NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210519 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3D PRINTED TITANIUM WAS PERFORMED ON (B)(6) 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18238362 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3DPRINTED TITANIUM WAS PERFORMED ON (B)(6) 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18238337 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON NOVEMBER 2, 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3D-PRINTED TITANIUM WAS PERFORMED ON SEPTEMBER 23, 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18238289 ↗
• InjuryNov 30, 2023Migration; Migration

  THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18238144 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON NOVEMBER 2, 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3DPRINTED TITANIUM WAS PERFORMED ON (B)(6) 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18237873 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3DPRINTED TITANIUM WAS PERFORMED ON (B)(6) 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18237599 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3DPRINTED TITANIUM WAS PERFORMED ON (B)(6) 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18237275 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3DPRINTED TITANIUM WAS PERFORMED ON (B)(6) 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18237043 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3DPRINTED TITANIUM WAS PERFORMED ON (B)(6) 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236952 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3DPRINTED TITANIUM WAS PERFORMED ON (B)(6) 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236806 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3DPRINTED TITANIUM WAS PERFORMED ON (B)(6) 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236664 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3DPRINTED TITANIUM WAS PERFORMED ON (B)(6) 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236639 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3DPRINTED TITANIUM WAS PERFORMED ON SEPTEMBER 23, 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236558 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON AN NOVEMBER 2, 2023 DUE TO NON UNION AND IMPLANT MIGRATION OF THE MAXILLA AREA. THE PATIENT MENTIONED SOMETHING "FELT LOOSE" IN THE AREA APPROXIMATELY 6 MONTHS PRIOR TO THE REVISION SURGERY. DURING THE SURGERY, ALL THE SCREWS WERE FOUND AND REMOVED. PATIENT WAS REVISED TO 3 L-PLATES AND SCREWS TO STABILIZE. INITIAL SURGERY USING CUSTOM 3DPRINTED TITANIUM WAS PERFORMED ON SEPTEMBER 23, 2019. PATIENT REPORTED THERE WAS NO NEW TRAUMA TO THE AREA AFTER THE INITIAL SURGERY. THIS REPORT IS FOR (B)(4) FOR 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236398 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT PLATES AND SCREWS FOR THE MAXILLA ON (B)(6) 2019. ABOUT SIX MONTHS AGO, THE PATIENT STATED THAT THEY FELT SOMETHING ¿LOOSE¿. PLATE AND SCREWS WERE REMOVED ON (B)(6) 2023, AND THE PLATE WAS FOUND TO BE BROKEN INTO EIGHT PIECES. THE PATIENT DID NOT HAVE ANY TRAUMA THAT COULD HAVE CAUSED THE SUDDEN BREAKAGE OF THE IMPLANT. THE BONE WAS NOT FULLY HEALED AT THE TIME OF IMPLANT REMOVAL ¿ THE MAXILLA WAS STILL MOBILE. IT REQUIRED THE IMPLANTATION OF THREE PLATS TO STABILIZE. THE REVISION WAS PERFORMED ON (B)(6) 2023. NO ADDITIONAL SURGERY IS ANTICIPATED. THIS REPORT INVOLVES ONE 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS IS REPORT 8 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236113 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT PLATES AND SCREWS FOR THE MAXILLA ON (B)(6), 2019. ABOUT SIX MONTHS AGO, THE PATIENT STATED THAT THEY FELT SOMETHING ¿LOOSE¿. PLATE AND SCREWS WERE REMOVED ON (B)(6), 2023, AND THE PLATE WAS FOUND TO BE BROKEN INTO EIGHT PIECES. THE PATIENT DID NOT HAVE ANY TRAUMA THAT COULD HAVE CAUSED THE SUDDEN BREAKAGE OF THE IMPLANT. THE BONE WAS NOT FULLY HEALED AT THE TIME OF IMPLANT REMOVAL ¿ THE MAXILLA WAS STILL MOBILE. IT REQUIRED THE IMPLANTATION OF THREE PLATS TO STABILIZE. THE REVISION WAS PERFORMED ON (B)(6), 2023. NO ADDITIONAL SURGERY IS ANTICIPATED. THIS REPORT INVOLVES ONE 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS IS REPORT 10 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236112 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT PLATES AND SCREWS FOR THE MAXILLA ON (B)(6), 2019. ABOUT SIX MONTHS AGO, THE PATIENT STATED THAT THEY FELT SOMETHING ¿LOOSE¿. PLATE AND SCREWS WERE REMOVED ON (B)(6), 2023, AND THE PLATE WAS FOUND TO BE BROKEN INTO EIGHT PIECES. THE PATIENT DID NOT HAVE ANY TRAUMA THAT COULD HAVE CAUSED THE SUDDEN BREAKAGE OF THE IMPLANT. THE BONE WAS NOT FULLY HEALED AT THE TIME OF IMPLANT REMOVAL ¿ THE MAXILLA WAS STILL MOBILE. IT REQUIRED THE IMPLANTATION OF THREE PLATS TO STABILIZE. THE REVISION WAS PERFORMED ON (B)(6), 2023. NO ADDITIONAL SURGERY IS ANTICIPATED. THIS REPORT INVOLVES ONE 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS IS REPORT 9 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236111 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT PLATES AND SCREWS FOR THE MAXILLA ON (B)(6) 2019. ABOUT SIX MONTHS AGO, THE PATIENT STATED THAT THEY FELT SOMETHING ¿LOOSE¿. PLATE AND SCREWS WERE REMOVED ON (B)(6) 2023, AND THE PLATE WAS FOUND TO BE BROKEN INTO EIGHT PIECES. THE PATIENT DID NOT HAVE ANY TRAUMA THAT COULD HAVE CAUSED THE SUDDEN BREAKAGE OF THE IMPLANT. THE BONE WAS NOT FULLY HEALED AT THE TIME OF IMPLANT REMOVAL ¿ THE MAXILLA WAS STILL MOBILE. IT REQUIRED THE IMPLANTATION OF THREE PLATS TO STABILIZE. THE REVISION WAS PERFORMED ON (B)(6) 2023. NO ADDITIONAL SURGERY IS ANTICIPATED. THIS REPORT INVOLVES ONE 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236109 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT PLATES AND SCREWS FOR THE MAXILLA ON (B)(6) 2019. ABOUT SIX MONTHS AGO, THE PATIENT STATED THAT THEY FELT SOMETHING ¿LOOSE¿. PLATE AND SCREWS WERE REMOVED ON (B)(6) 2023, AND THE PLATE WAS FOUND TO BE BROKEN INTO EIGHT PIECES. THE PATIENT DID NOT HAVE ANY TRAUMA THAT COULD HAVE CAUSED THE SUDDEN BREAKAGE OF THE IMPLANT. THE BONE WAS NOT FULLY HEALED AT THE TIME OF IMPLANT REMOVAL ¿ THE MAXILLA WAS STILL MOBILE. IT REQUIRED THE IMPLANTATION OF THREE PLATS TO STABILIZE. THE REVISION WAS PERFORMED ON (B)(6) 2023. NO ADDITIONAL SURGERY IS ANTICIPATED. THIS REPORT INVOLVES ONE 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236108 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT PLATES AND SCREWS FOR THE MAXILLA ON (B)(6), 2019. ABOUT SIX MONTHS AGO, THE PATIENT STATED THAT THEY FELT SOMETHING ¿LOOSE¿. PLATE AND SCREWS WERE REMOVED ON (B)(6), 2023, AND THE PLATE WAS FOUND TO BE BROKEN INTO EIGHT PIECES. THE PATIENT DID NOT HAVE ANY TRAUMA THAT COULD HAVE CAUSED THE SUDDEN BREAKAGE OF THE IMPLANT. THE BONE WAS NOT FULLY HEALED AT THE TIME OF IMPLANT REMOVAL ¿ THE MAXILLA WAS STILL MOBILE. IT REQUIRED THE IMPLANTATION OF THREE PLATS TO STABILIZE. THE REVISION WAS PERFORMED ON (B)(6), 2023. NO ADDITIONAL SURGERY IS ANTICIPATED. THIS REPORT INVOLVES ONE 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236105 ↗
• InjuryNov 30, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT PLATES AND SCREWS FOR THE MAXILLA ON (B)(6), 2019. ABOUT SIX MONTHS AGO, THE PATIENT STATED THAT THEY FELT SOMETHING ¿LOOSE¿. PLATE AND SCREWS WERE REMOVED ON (B)(6), 2023, AND THE PLATE WAS FOUND TO BE BROKEN INTO EIGHT PIECES. THE PATIENT DID NOT HAVE ANY TRAUMA THAT COULD HAVE CAUSED THE SUDDEN BREAKAGE OF THE IMPLANT. THE BONE WAS NOT FULLY HEALED AT THE TIME OF IMPLANT REMOVAL ¿ THE MAXILLA WAS STILL MOBILE. IT REQUIRED THE IMPLANTATION OF THREE PLATS TO STABILIZE. THE REVISION WAS PERFORMED ON (B)(6), 2023. NO ADDITIONAL SURGERY IS ANTICIPATED. THIS REPORT INVOLVES ONE 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS IS REPORT 5 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18236104 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORTHOGNATHIC SURGERY INVOLVING THE UPPER AND LOWER JAW ON (B)(6) 2023. IT HAS BEEN DETERMINED BY THE SURGEON AND ORTHODONTIST THAT THE MAXILLARY SURGERY IS STABLE, HOWEVER, THE MANDIBULAR PORTION IS NOT AND MUST BE REVISED. IMAGING PERFORMED ON AN UNKNOWN DATE SHOWED UNSTABLE FIXATION AND MALOCCLUSION, SO A REVISION SURGERY IS PLANNED FOR THE NEAR FUTURE. THIS REPORT INVOLVES ONE 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM. THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17451304 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORTHOGNATHIC SURGERY INVOLVING THE UPPER AND LOWER JAW ON (B)(6) 2023. IT HAS BEEN DETERMINED BY THE SURGEON AND ORTHODONTIST THAT THE MAXILLARY SURGERY IS STABLE, HOWEVER, THE MANDIBULAR PORTION IS NOT AND MUST BE REVISED. IMAGING PERFORMED ON AN UNKNOWN DATE SHOWED UNSTABLE FIXATION AND MALOCCLUSION, SO A REVISION SURGERY IS PLANNED FOR THE NEAR FUTURE. THIS REPORT INVOLVES ONE 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17451289 ↗

Recalls under the same FDA submission

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

• 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