NA 412.134SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982210821), received between Nov 10, 2025 and Nov 10, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (4 reports).

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

• InjuryNov 10, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH THE PLATE AND THE LOCKING SCREW; THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE FIRST SURGERY, IT WAS CONFIRMED THAT THE SCREW WAS BROKEN AND THE PLATE DISPLACED. X-RAYS SHOWED THAT THE LOCKING SCREW INSERTED AT THE MOST DISTAL END OF THE PLATE HAD BROKEN, AND THE DISTAL END OF THE PLATE HAD DISPLACED AND FLOATED OFF THE BONE.

  Patient problems: Insufficient Information

  MAUDE report 23512185 ↗
• InjuryNov 10, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2025, THE SURGEON REPORTED THAT THE PATIENT WAS UNABLE TO UNDERGO REHABILITATION DUE TO PAIN AND WISHED TO HAVE THE PLATE REMOVED AS SOON AS POSSIBLE. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2025. THE DETAILS FOR THE SURGERY IS REPORTED IN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 23512102 ↗
• InjuryNov 10, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2025, THE SURGEON REPORTED THAT THE PATIENT WAS UNABLE TO UNDERGO REHABILITATION DUE TO PAIN AND WISHED TO HAVE THE PLATE REMOVED AS SOON AS POSSIBLE. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2025. THE DETAILS FOR THE SURGERY IS REPORTED IN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 23512091 ↗
• InjuryNov 10, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH THE PLATE AND THE LOCKING SCREW; THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE FIRST SURGERY, IT WAS CONFIRMED THAT THE SCREW WAS BROKEN AND THE PLATE DISPLACED. X-RAYS SHOWED THAT THE LOCKING SCREW INSERTED AT THE MOST DISTAL END OF THE PLATE HAD BROKEN, AND THE DISTAL END OF THE PLATE HAD DISPLACED AND FLOATED OFF THE BONE.

  Patient problems: Insufficient Information

  MAUDE report 23511701 ↗

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,