Calf Implant, Textured, (Carlsen) SDM Size: 25.0cm x 10.5cm x 2.0cm, Right SideRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M724CCB7TC3R1), received between Nov 16, 2018 and Nov 16, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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.

• InjuryNov 16, 2018Inadequacy of Device Shape and/or Size

  (NOTE: THIS IS THE SAME PATIENT AND SAME EVENT BEING REPORTED IN MEDWATCH REPORT # 2028924-2018-00008.) COMPLAINANT REPORTED THAT THE DIMENSIONS OF THE IMPLANTS DID NOT MATCH THOSE THAT WE HAVE LISTED. THE INITIAL REPORT INDICATED THAT THE PATIENT HAD BEEN PUT UNDER ANESTHESIA, AND THEY HAD TO WAKE HER UP WITHOUT DOING THE SURGERY DUE TO THEIR CONCERNS REGARDING THE DIMENSIONS. SUBSEQUENT FOLLOW-UP REVELED THAT THE PATIENT HAD OTHER SURGICAL PROCEDURES PERFORMED ON THAT DATE, AND THAT THE INTENDED SURGERY TO IMPLANT THE "SUBJECT" DEVICES WAS NOT THE SOLE REASON WHY THE PATIENT WAS PLACED UNDER ANESTHESIA. NO SUBSEQUENT INTERVENTION HAS BEEN REPORTED. THOUGH THERE IS NO CLEAR INFORMATION THAT THE REPORTED EVENT NECESSARILY CONSTITUTES A SERIOUS INJURY, IMPLANTECH HAS ELECTED TO REPORT THIS EVENT IN THE ABUNDANCE OF CAUTION. (NOTE: THE EVENT DATE WILL BE CONSIDERED TO BE (B)(6) 2018, THE DATE OF THE SURGERY IN WHICH "SUBJECT" DEVICES WERE NOT IMPLANTED DUE TO THE CONCERNS REPORTED ABOVE.)

  Patient problems: No Code Available

  MAUDE report 8081381 ↗