NA 202.816Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982144744), received between Jan 13, 2021 and Apr 22, 2021 — 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. 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 5 most recent of 5 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 16MM. THIS REPORT IS 6 OF 7 (B)(4).

  Patient problems: Pain

  MAUDE report 11709178 ↗
• 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 16MM THIS REPORT IS 4 OF 7 (B)(4).

  Patient problems: Pain

  MAUDE report 11709169 ↗
• 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 16MM THIS REPORT IS 5 OF 7 (B)(4).

  Patient problems: Pain

  MAUDE report 11709167 ↗
• 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 16MM. THIS REPORT IS 1 OF 7 (B)(4).

  Patient problems: Pain

  MAUDE report 11709165 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN SURGERY, LOCKING COMPRESSION PLATE, CORTEX SCREWS, AND LOCKING SCREWS WERE TAKEN OUT DUE TO PATIENT PAIN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1); 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM (PART NUMBER 02.112.048, LOT UNKNOWN, QUANTITY 1); 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 16MM (PART NUMBER 212.104, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 14MM (PART NUMBER 204.814, LOT UNKNOWN, QUANTITY 1); 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1); 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART NUMBER 02.211.016, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 16MM. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11163079 ↗