OsteoMed 204-1206Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00845694000482), received between May 16, 2022 and May 16, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: 1) THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR 2) THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN. IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2 MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00019, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00023, AND 2027754-2022-00024.

  Patient problems: Foreign Body In Patient

  MAUDE report 14412616 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: 1) THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR 2) THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN. IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2 MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00019, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00023, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14412574 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR WAS NOT STRAIGHT OR THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN. IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKES BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00019, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00024, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14412518 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN. IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKES BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00019, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00023, 2027754-2022-00024, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14412430 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN. IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKES BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00019, 2027754-2022-00020, 2027754-2022-00022, 2027754-2022-00023, 2027754-2022-00024, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14412286 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: 1) THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR 2) THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN. IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKES BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00019, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00023, 2027754-2022-00024, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14412055 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: 1) THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR 2) THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN. IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKES BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00019, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00023, 2027754-2022-00024, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14411380 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN. IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKES BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00018, 2027754-2022-00019, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00023, 2027754-2022-00024, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14411371 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: 1) THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR 2) THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN.IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKES BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00023, 2027754-2022-00024, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14411309 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKES BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00019, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00023, 2027754-2022-00024, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14410548 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN. IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKES BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00019, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00023, 2027754-2022-00024, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14410466 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: 1) THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR 2) THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN. IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKES BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00019, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00023, 2027754-2022-00024, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14410397 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN. IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKES BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00012, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00019, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00023, 2027754-2022-00024, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14410235 ↗
• MalfunctionMay 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A FACIAL TRAUMA PROCEDURE, THE SURGEON USED THE PART NUMBER 204-1206 SCREWS, AND ONE OF THE FOLLOWING SITUATIONS OCCURRED: THE SCREW COULD NOT BE INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN OR "WAS NOT STRAIGHT" OR THE SCREW WAS INSERTED INTO BONE, AND THEN, THE SCREW WAS BROKEN. IT WAS REPORTED PREDRILLING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT; HOWEVER, IT WAS REPORTED THIS ISSUE RESULTED IN DELAY IN PROCEDURE AND FRAGMENT OF THE BROKEN SCREW REMAINS IN THE PATIENT. IT IS UNKNOWN HOW MANY SCREWS BROKES BROKE/FRAGMENTS REMAIN IN PATIENT. THE SURGEON USED 1.2MM SCREW WITH ANOTHER LENGTH TO COMPLETE THE SURGERY. INFORMATION RECEIVED INDICATED 14 SCREWS FROM THREE DIFFERENT BATCH/LOT NUMBERS WERE INVOLVED. THIS REPORT IS RELATED TO THE FOLLOWING REPORT NUMBERS FOR THE OTHER SCREWS INVOLVED IN THIS EVENT: 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00019, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00023, 2027754-2022-00024, AND 2027754-2022-00025.

  Patient problems: Foreign Body In Patient

  MAUDE report 14409441 ↗