NA 211.848Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982151711), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K012945, K161616); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FRACTURE FIXATION FOR AN UNKNOWN FRACTURE UTILIZING A 2.4 MM CANNULATED SCREW. POSTOPERATIVELY THE PATIENT HAD DISCOMFORT, PROMINENT IMPLANT REPORTED. REHOSPITALIZATION WAS DUE TO DPS IMPLANTS. NO SURGICAL REVISION WAS NECESSARY AS THERE WAS A UNION OF FRACTURE ACHIEVED UNTIL 12 WEEKS POST OP. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) 2.4MM CANNULATED SCREW SHORT THREAD 28MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Discomfort

  MAUDE report 12821972 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012945, K161616. One submission often covers many models, so check the product and lot details in each record.

• Z-0890-2013 · Feb 12, 2013 · Terminated
  Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antiprur