NA 212.112Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982151865), received between Apr 8, 2019 and Oct 29, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE SURGEON COMMENTED THAT THE DISTAL FIBULA PLATE WAS TOO BULKY AND DECIDED TO REMOVE IT IN EXCHANGE FOR A 1/3 TUBULAR PLATE ON THE FIBULA. WHILE USING A 1/3 TUBULAR ON THE MEDIAL SIDE OF THE TIBIA, THE SURGEON COULD NOT GET THE LOCKING MECHANISM TO FUNCTION, HOWEVER, IT WAS POSSIBLE THAT THE LOCKING HOLE WAS DEFORMED BY PUTTING A PREVIOUS NON-LOCKING SCREW. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 32. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719760 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON MARCH 14, 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 DECEMBER 23, 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(TM) 32MM. THIS IS REPORT 10 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8492109 ↗

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,