NA 211.818Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982151568), received between Nov 16, 2021 and Nov 16, 2021 — classified as 2 injuries.

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 18, 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.

• 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 PROCEDURE FOR AN EXTRAARTICULAR FRACTURE ON AN UNKNOWN DATE, UTILIZING A 2.4 MM CANNULATED SCREW. THERE WAS A POSTOPERATIVE COMPLICATION REPORTED. THE POSTOPERATIVE COMPLICATIONS REPORTED WERE DISCOMFORT AND DECREASED IN RANGE OF MOTION. PATIENT WAS HOSPITALIZED DUE TO HARDWARE REMOVAL. NO SURGICAL REVISION WAS NECESSARY AS THERE WAS A UNION OF FRACTURE ACHIEVED UNTIL 16 WEEKS POST OP. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 2.4MM CANNULATED SCREW LONG THREAD 18MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Discomfort; Loss of Range of Motion

  MAUDE report 12821108 ↗
• 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 PROCEDURE FOR AN EXTRAARTICULAR FRACTURE ON AN UNKNOWN DATE, UTILIZING A 2.4 MM CANNULATED SCREW. THERE WAS A POSTOPERATIVE COMPLICATION REPORTED. THE POSTOPERATIVE COMPLICATIONS REPORTED WERE DISCOMFORT AND DECREASED IN RANGE OF MOTION. PATIENT WAS HOSPITALIZED DUE TO HARDWARE REMOVAL. NO SURGICAL REVISION WAS NECESSARY AS THERE WAS A UNION OF FRACTURE ACHIEVED UNTIL 16 WEEKS POST OP. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 2.4MM CANNULATED SCREW LONG THREAD 18MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Discomfort; Loss of Range of Motion

  MAUDE report 12821103 ↗

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