Daytona Small Stature 76-0047Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981161293), received between Aug 27, 2021 and Aug 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Disconnect” (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.

• MalfunctionAug 27, 2021Loose or Intermittent Connection; Failure to Disconnect; Loose or Intermittent Connection; Failure to Disconnect

  USERS REPORTED THAT DURING A REVISION SURGERY TO REPOSITION THE PATIENT'S EXISTING GROWING ROD CONSTRUCT, INTRA-OPERATIVE MALFUNCTIONS OF THE MATERIALS WERE REPORTED. HOWEVER, SUBSEQUENT EVALUATION NOTED THE COMPONENTS HAD BEEN IMPLANTED IN THE FIRST SURGERY AND EXHIBITED SIGNS OF POST-OPERATIVE LOOSENING. BASED ON THE RESULS OF THE EVALUATION THE EVENT WAS DEEMED REPORTABLE WITH THE AWARENESS DATE OF (B)(6) 2021. THE LOOSENING WAS ASYMPTOMATIC AND WAS NOT NOTED DURING THE REVISION SURGERY. AVAILABLE INFORMATION SUGGESTS THAT THE GROWING ROD CONSTRUCT WAS INTENDED TO BE ADJUSTED AND COMPONENTS WERE NOT INTENDED TO BE REPLACED. HOWEVER, THE LOCK SCREW REPORTEDLY BECAME DEFORMED DURING THESE MANEUVERS AND COULD NOT BE REMOVED; THE ROD WAS CUT AND A ROD-ROD CONNECTOR WAS PLACED TO RE-CONNECT THE CONSTRUCT PORTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380713 ↗