NA 212.120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982151940), received between Jan 19, 2018 and Jul 21, 2022 — classified as 5 injuries.

1 other recall cover devices cleared under the same FDA submission (K000684, K072095); they may or may not involve this specific model.

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 16, 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.

• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWS IN QUESTION WERE REMOVED DUE TO LONGER SIZES BEING NECESSARY. THE PATIENT DID NOT EXPERIENCE A POST-OP DEVICE MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 48MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15077837 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT PROXIMAL HUMERUS DUE TO NONUNION. THE FOLLOWING HARDWARE WAS REMOVED: ONE (1) LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE-STANDARD 3H HEAD SHAFT. ONE (1) CORTEX SCREW SELF-TAPPING 34MM. ONE (1) CORTEX SCREW SELF-TAPPING 30MM. TWO (2) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 52MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 40MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 48MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 38MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 50MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 46MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 32MM. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. ALL HARDWARE WAS REMOVED SUCCESSFULLY AND INTACT. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.5MM LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 48MM. THIS IS REPORT 6 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8491650 ↗
• InjuryDec 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE DUE TO AN INJURY. THE OPEN DISTAL TIBIA FRACTURE WAS PLATED WITH ONE (1) MEDIAL DISTAL TIBIA PLATE AND ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE. THE FIBULA WAS ALSO PLATED WITH ONE (1) ONE-THIRD (1/3) TUBULAR PLATE. THE PATIENT HAD AN INFECTION DUE TO THE OPEN FRACTURE AND WAS MADE AWARE ON (B)(6) 2018. A HARDWARE REMOVAL WAS CONDUCTED ON (B)(6) 2018 FOR ALL PLATES INCLUDING ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE (TM) RECESS 50MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 42MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 40MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 18MM, TWO (2) 2.7MM CORTEX SCREW SELF-TAPPING 32MM, ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 36MM, TWO (2) 3.5MM CORTEX SCREW SELF-TAPPING 38MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 36MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 34MM, FIVE (5) 3.5MM CORTEX SCREW SELF-TAPPING 32MM, AND ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 30MM. IRRIGATION AND DEBRIDEMENT WAS PERF

  Patient problems: Unspecified Infection

  MAUDE report 8193011 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT OSTEOSYNTHESIS OF PROXIMAL HUMERUS WITH A 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE AND SEVEN (7) SCREWS ON (B)(6) 2017. PROCEDURE WAS COMPLETED SUCCESSFULLY. POST-OPERATIVELY IT WAS NOTED THE PLATE WAS BROKEN. IT WAS ALSO NOTED THAT PATIENT BONE HAS NECROSIS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 WITHOUT ANY ISSUES. IMPLANTS WERE REMOVED. PATIENT WILL RECEIVE UNSPECIFIED ADDITIONAL TREATMENT PRIOR TO IMPLANTING NEW MATERIAL. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 48MM . THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: Necrosis; No Code Available

  MAUDE report 7207560 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT OSTEOSYNTHESIS OF PROXIMAL HUMERUS WITH A 3.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE AND SEVEN (7) SCREWS ON (B)(6) 2017. PROCEDURE WAS COMPLETED SUCCESSFULLY. POST-OPERATIVELY IT WAS NOTED THE PLATE WAS BROKEN. IT WAS ALSO NOTED THAT PATIENT BONE HAS NECROSIS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 WITHOUT ANY ISSUES. IMPLANTS WERE REMOVED. PATIENT WILL RECEIVE UNSPECIFIED ADDITIONAL TREATMENT PRIOR TO IMPLANTING NEW MATERIAL. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 48MM . THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Necrosis; No Code Available

  MAUDE report 7207488 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K072095. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,