NA 401.942ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587048079), received between Mar 14, 2019 and Mar 18, 2019 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FURTHER IT WAS REPORTED THAT THE HARDWARE REMOVAL PROCEDURE WAS PERFORMED ON (B)(6) 2019. PATIENT OUTCOME REPORTED AS FINE AND SUFFERED NO ADVERSE EVENTS, HOWEVER THEY WERE NOT HAPPY THAT THE SURGERY WAS ELONGATED.

  Patient problems: Unspecified Infection

  MAUDE report 8428979 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE; THE PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO INFECTION. THERE TWO (2) TITANIUM BROAD PLATE 6 HOLES, ONE (1)TITANIUM LARGE LOCKING PLATE 12 HOLES, FIVE (5) TITANIUM CORETX SCREW SELF-TAPPING WITH FLUTES 6MM, ONE (1) TITANIUM EMERGENCY SCREW 6MM, FIVE (5) TITANIUM CORTEX SCREW COARSE PITCH SELF-TAPPING 12MM, TWO (2) TITANIUM CORTEX SCREW COARSE PITCH SELF-TAPPING 14MM, ONE (1) TITANIUM CORTEX SCREW COARSE PITCH SELF-TAPPING 10MM, FOUR (4) TITANIUM EMERGENCY SCREW 12MM IMPLANTED IN (B)(6) 2018. ONE OF THE THREE PLATES IMPLANTED BECAME INFECTED, AND PATIENT WANTED THEM TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FOUR (4) HOURS SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL TWENTY-ONE (21) DEVICES. THIS COMPLAINT CAPTURES TEN (10) DEVICES. DUE TO SYSTEM LIMITATION REMAINING ELEVEN (11) DEVICES ARE CAPTURED IN THE RELATED COMPLAINTS (B)(4). THIS REPORT IS FOR ONE (1) 2.0MM TI CORTEX SCREW COARSE PITCH SELF-TAPPING 12MM. THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8421252 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE; THE PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO INFECTION. THERE TWO (2) TITANIUM BROAD PLATE 6 HOLES, ONE (1)TITANIUM LARGE LOCKING PLATE 12 HOLES, FIVE (5) TITANIUM CORETX SCREW SELF-TAPPING WITH FLUTES 6MM, ONE (1) TITANIUM EMERGENCY SCREW 6MM, FIVE (5) TITANIUM CORTEX SCREW COARSE PITCH SELF-TAPPING 12MM, TWO (2) TITANIUM CORTEX SCREW COARSE PITCH SELF-TAPPING 14MM, ONE (1) TITANIUM CORTEX SCREW COARSE PITCH SELF-TAPPING 10MM, FOUR (4) TITANIUM EMERGENCY SCREW 12MM IMPLANTED IN (B)(6) 2018. ONE OF THE THREE PLATES IMPLANTED BECAME INFECTED, AND PATIENT WANTED THEM TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FOUR (4) HOURS SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL TWENTY-ONE (21) DEVICES. THIS COMPLAINT CAPTURES TEN (10) DEVICES. DUE TO SYSTEM LIMITATION REMAINING ELEVEN (11) DEVICES ARE CAPTURED IN THE RELATED COMPLAINTS (B)(4). THIS REPORT IS FOR ONE (1) 2.0MM TI CORTEX SCREW COARSE PITCH SELF-TAPPING 12MM. THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8421251 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO INFECTION. THERE TWO (2) TITANIUM BROAD PLATE 6 HOLES, ONE (1)TITANIUM LARGE LOCKING PLATE 12 HOLES, FIVE (5) TITANIUM CORTEX SCREW SELF-TAPPING WITH FLUTES 6MM, ONE (1) TITANIUM EMERGENCY SCREW 6MM, FIVE (5) TITANIUM CORTEX SCREW COARSE PITCH SELF-TAPPING 12MM, TWO (2) TITANIUM CORTEX SCREW COARSE PITCH SELF-TAPPING 14MM, ONE (1) TITANIUM CORTEX SCREW COARSE PITCH SELF-TAPPING 10MM, FOUR (4) TITANIUM EMERGENCY SCREW 12MM IMPLANTED IN (B)(6) 2018. ONE OF THE THREE PLATES IMPLANTED BECAME INFECTED, AND PATIENT WANTED THEM TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FOUR (4) HOURS SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL TWENTY-ONE (21) DEVICES. THIS COMPLAINT CAPTURES TEN (10) DEVICES. DUE TO SYSTEM LIMITATION REMAINING ELEVEN (11) DEVICES ARE CAPTURED IN THE RELATED COMPLAINTS (B)(4). THIS REPORT IS FOR ONE (1) 2.0MM TI CORTEX SCREW COARSE PITCH SELF-TAPPING 12MM. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8421219 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE; THE PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO INFECTION. THERE TWO (2)TITANIUM BROAD PLATE 6 HOLES, ONE (1)TITANIUM LARGE LOCKING PLATE 12 HOLES, FIVE (5) TITANIUM CORETX SCREW SELF-TAPPING WITH FLUTES 6MM, ONE (1) TITANIUM EMERGENCY SCREW 6MM, FIVE (5) TITANIUM CORTEX SCREW COARSE PITCH SELF-TAPPING 12MM, TWO (2) TITANIUM CORTEX SCREW COARSE PITCH SELF-TAPPING 14MM, ONE (1) TITANIUM CORTEX SCREW COARSE PITCH SELF-TAPPING 10MM, FOUR (4) TITANIUM EMERGENCY SCREW 12MM IMPLANTED IN (B)(6) 2018. ONE OF THE THREE PLATES IMPLANTED BECAME INFECTED, AND PATIENT WANTED THEM TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH FOUR (4) HOURS SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL TWENTY-ONE (21) DEVICES. THIS COMPLAINT CAPTURES TEN (10) DEVICES. DUE TO SYSTEM LIMITATION REMAINING ELEVEN (11) DEVICES ARE CAPTURED IN THE RELATED COMPLAINTS (B)(4). THIS REPORT IS FOR ONE (1) 2.0MM TI CORTEX SCREW COARSE PITCH SELF-TAPPING 12MM. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8421159 ↗