NA 02.212.054Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982055200), received between Feb 5, 2019 and Feb 5, 2019 — classified as 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); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, A 3.5MM LOCKING SCREW WAS NOT HAVING THE SAME BITE OR PURCHASE WHEN BEING INSERTED INTO THE UNKNOWN PLATE. IT WAS NOT ONE SPECIFIC SCREW AS THE PITCH OF THE SCREW APPEARS TO BE DIFFERENT FROM THE PREVIOUS UNKNOWN SCREWS. THERE WERE OTHER UNKNOWN SCREWS THAT HAVE BEEN THE ISSUE AS WELL. ANOTHER LOCKING SCREW IN THE SET OF THE SAME LENGTH WAS USED TO COMPLETE THE PROCEDURE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIVE (5) MINUTE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 3.5MM LOCKING SCREW SELF-TAPPING 54MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8307450 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. 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,