NA 04.214.110Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982120854), received between Jul 12, 2018 and May 6, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, AT THE TIME OF SCREW INSERTION, THE SCREW BROKE OFF AT THE THREADED PART SLIGHTLY BELOW THE SCREW HEAD JUST BEFORE THE SCREW HEAD HIT THE CORTEX IN FRONT OF IT. THE SCREW WAS INSERTED DIRECTLY, NOT THROUGH THE PLATE, AND THE TORQUE LOAD WAS NOT HIGH. ALL EQUIPMENT COMPLIED WITH THE SPECIFICATIONS. THE BROKEN SCREW WAS REMOVED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 20 MINUTES DUE TO THE REMOVAL OF THE PLATE THAT HAD ALREADY BEEN INSTALLED IN ORDER TO REMOVE THE BROKEN SCREW. THIS REPORT INVOLVES ONE 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19254831 ↗
• MalfunctionMar 26, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, WHILE THE SPECIALIST WAS FIXING THE PLATE WITH ONE OF THE CORTICAL SCREWS IN QUESTION, WHEN TIGHTENING THE SCREW IT SPLIT, LEAVING THE BODY OF THE SCREW IN THE PATIENT AND THE HEAD IN THE SCREWDRIVER. THE SPECIALIST ASKED FOR A SECOND SCREW TO ATTEMPT AGAIN, BUT THIS ALSO BREAKS IN THE SAME WAY. SURGERY WAS COMPLETED SUCCESSFULLY BY PASSING ANOTHER SCREW. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 10 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18981670 ↗
• MalfunctionMar 26, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, WHILE THE SPECIALIST WAS FIXING THE PLATE WITH ONE OF THE CORTICAL SCREWS IN QUESTION, WHEN TIGHTENING THE SCREW IT SPLIT, LEAVING THE BODY OF THE SCREW IN THE PATIENT AND THE HEAD IN THE SCREWDRIVER. THE SPECIALIST ASKED FOR A SECOND SCREW TO ATTEMPT AGAIN, BUT THIS ALSO BREAKS IN THE SAME WAY. SURGERY WAS COMPLETED SUCCESSFULLY BY PASSING ANOTHER SCREW. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 10 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM. THIS IS REPORT 1 OF 2 FOR (B)(4) .

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18981668 ↗
• MalfunctionMar 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) FINGER. WHEN IMPLANTING A 1.5 TITANIUM CORTEX SCREW FROM THE VA HANDSET IT STRIPPED AND WAS DIFFICULT TO REMOVE. THE SURGEON STRIPPED TWO T4 SCREWDRIVERS WHILE ATTEMPTING TO REMOVE THE SCREW. THEY ARE NOW WARPED AND UNABLE TO USE. THE SCREW WAS GOING TO BE REMOVED BECAUSE IT HAD NO PURCHASE IN THE BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BUT THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE PROCEDURE WAS COMPLETED. THIS REPORT INVOLVES ONE (1) UNKNOWN SCREWS: CORTEX: TRAUMA. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13768972 ↗
• InjuryApr 12, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TWO (2) TITANIUM CORTEX SCREW SHEERED OFF IN PATIENT DURING INSERTION. THE PROPER TECHNIQUE WAS USED IN DRILLING WITH THE 1.1 MM DRILL, DEPTH WAS MEASURED, SCREW WAS PUT IN WITH T4 DRIVER. PROPER INSTRUMENTATION AND PROTOCOL WAS DONE DURING THE PROCEDURE. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND WERE DIFFICULT TO REMOVE. BROKEN SCREWS WERE REMOVED AND THROWN AWAY POST CASE. THERE WAS A MEDICAL INTERVENTION OF BURRING/DRILLING AND USE OF DEMINERALIZED BONE MATRIX (DBX) THAT WAS NEEDED AFTER. SURGEON COMPLETED THE PROCEDURE BY USING COMBINATION OF 1.5 CORTEX SCREWS AND 1.5 VARIABLE ANGLE LOCKING SCREWS WITH A 1.5 PLATE. SURGEON FILLED BONE VOID CAUSED BY REMOVING BROKEN SCREWS WITH DBX. THERE WAS A SURGICAL DELAY OF ABOUT FORTY-FIVE (45) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8511174 ↗
• InjuryApr 12, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TWO (2) TITANIUM CORTEX SCREW SHEERED OFF IN PATIENT DURING INSERTION. THE PROPER TECHNIQUE WAS USED IN DRILLING WITH THE 1.1 MM DRILL, DEPTH WAS MEASURED, SCREW WAS PUT IN WITH T4 DRIVER. PROPER INSTRUMENTATION AND PROTOCOL WAS DONE DURING THE PROCEDURE. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND WERE DIFFICULT TO REMOVE. BROKEN SCREWS WERE REMOVED AND THROWN AWAY POST CASE. THERE WAS A MEDICAL INTERVENTION OF BURRING/DRILLING AND USE OF DEMINERALIZED BONE MATRIX (DBX) THAT WAS NEEDED AFTER. SURGEON COMPLETED THE PROCEDURE BY USING COMBINATION OF 1.5 CORTEX SCREWS AND 1.5 VARIABLE ANGLE LOCKING SCREWS WITH A 1.5 PLATE. SURGEON FILLED BONE VOID CAUSED BY REMOVING BROKEN SCREWS WITH DBX. THERE WAS A SURGICAL DELAY OF ABOUT FORTY-FIVE (45) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8511172 ↗
• MalfunctionJul 12, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN IMPLANT PLACEMENT PROCEDURE ON (B)(6) 2018, THE HEADS OF TWO TITANIUM (TI) CORTEX SCREWS BROKE DUE TO THE WORN TIP OF TWO (2) STARDRIVE SCREWDRIVER SHAFTS. ALL DEVICE FRAGMENTS WERE EASILY REMOVED AND NEW SCREWS WERE IMPLANTED TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPORTED DELAY OF FORTY FIVE (45) MINUTES. THERE IS NO OTHER REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7681273 ↗
• MalfunctionJul 12, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN IMPLANT PLACEMENT PROCEDURE ON (B)(6) 2018, THE HEADS OF TWO TITANIUM (TI) CORTEX SCREWS BROKE DUE TO THE WORN TIP OF TWO (2) STARDRIVE SCREWDRIVER SHAFTS. ALL DEVICE FRAGMENTS WERE EASILY REMOVED AND NEW SCREWS WERE IMPLANTED TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPORTED DELAY OF FORTY FIVE (45) MINUTES. THERE IS NO OTHER REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A 1.5MM TI CORTEX SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7681164 ↗