NA 202.818Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982144751), received between Jul 3, 2018 and Apr 22, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY. DURING THE SURGERY, FOUR (4) 2.7MM CORTEX SCREW SELF-TAPPING 16MM, TWO (2) 2.7MM CORTEX SCREW-TAPPING 18MM AND ONE (1) 2.7MM LC-DCP PLATE 6 HOLES WERE REMOVED DUE TO PAIN. NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 2.7MM CORTEX SCREW SELF-TAPPING 18MM. THIS REPORT IS 2 OF 7 (B)(4).

  Patient problems: Pain

  MAUDE report 11709164 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY. DURING THE SURGERY, FOUR (4) 2.7MM CORTEX SCREW SELF-TAPPING 16MM, TWO (2) 2.7MM CORTEX SCREW-TAPPING 18MM AND ONE (1) 2.7MM LC-DCP PLATE 6 HOLES WERE REMOVED DUE TO PAIN. NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 2.7MM CORTEX SCREW SELF-TAPPING 18MM. THIS REPORT IS 7 OF 7 (B)(4).

  Patient problems: Pain

  MAUDE report 11709137 ↗
• InjuryDec 18, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TIBIA SHAFT SURGERY ON (B)(6) 2018. DURING THE PROCEDURE, A CORTEX SCREW HEAD BROKE OFF DURING FINAL TIGHTENING DUE TO PATIENTS HARD BONE. BROKEN FRAGMENTS WERE REMOVED USING A SCREW REMOVAL SET ON THE SCREW SHAFT WITH TREPHINE AND A CONICAL REMOVAL TOOLS. A LOCKING COMPRESSION DYNAMIC COMPRESSION PLATE WAS SELECTED AS PROVISION FIXATION PRIOR TO INTRAMEDULLARY NAILING. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS AS PLANNED. CONCOMITANT DEVICE REPORTED: LOCKING COMPRESSION DYNAMIC COMPRESSION PLATE (PART # 242.206, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8173619 ↗
• MalfunctionJul 3, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A SURGICAL PROCEDURE OF A BROKEN PALM FRACTURE TO FIX ULNA WITH A LOCKING COMPRESSION PLATE (LCP). UPON INSERTION OF THE FINAL CORTEX SCREW, THE HEAD OF THE SCREW CAME OFF. THE SURGEON DECIDED TO REMOVE THE ENTIRE CONSTRUCT TO REMOVE THE SCREW FRAGMENT AND UPON AN ATTEMPT TO REMOVE THE NEXT SCREW IN THE PLATE, THE SCREW CAME OFF. THE SURGEON REMOVED ALL THE SCREWS AND THE PLATE. A BROKEN SCREW REMOVAL SET WAS USED TO TAKE OUT THE SCREW FRAGMENT. THERE WAS A SURGICAL DELAY OF AN HOUR REPORTED TO AN ATTEMPT TO REMOVE THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: SCREWS (PART 202.873, LOT UNKNOWN, QUANTITY 3), 2.7MM CORTEX SCREW, SELF-TAPPING 16MM (PART 202.876, LOT UNKNOWN, QUANTITY 1), 2.7MM CORTEX SCREW, SELF-TAPPING 20MM (PART 202.880, LOT UNKNOWN, QUANTITY 1), 2.0MM LOCKING COMPRESSION PLATE 7 HOLES (PART 247.347, LOT NUMBER UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7658986 ↗