SMART TSF 71075401Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556746370), received between Aug 16, 2022 and Feb 15, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT, AFTER AN EXTERNAL FIXATION PROCEDURE WITH A TAYLOR SPATIAL FRAME, DONE ON (B)(6) 2022, TO CORRECT AN EQUINUS DEFORMITY, AND AFTER A COUPLE OF POST-OP VISITS, THE PATIENT COMPLAINED OF EXCESSIVE PAIN, AND WANTED TO HAVE THE FRAME REMOVED. THE PATIENT REMOVED A PORTION OF HIS RING OFF AND WAS UNABLE TO FOLLOW THE ADJUSTMENT SCHEDULE THROUGHOUT, THE FIRST 40 DAYS SCHEDULED BY THE DOCTOR WERE COMPLETED IN 10 DAYS. THE POST OPERATIVE ADJUSTMENT SCHEDULE MADE WITH THE SMART TSF.COM WEB APPLICATION WAS REVISED BY THE TSF ALLY TEAM, AND HAD TO BE DONE MULTIPLE TIMES DUE TO ERRORS MADE BY THE DOCTOR AND ACCIDENTAL DELETIONS OF THE PROGRAM. DURING A TROUBLESHOOTING CALL MADE WITH THE SURGEON ON (B)(6) 2022, IT WAS NOTICED THAT THE DOCTOR MADE AN ERROR WHEN CONVERTING FROM X-RAY MODE (PROGRAM PROVIDED BY TSF ALLY TEAM) TO MANUAL MODE, ALSO STRUT SETTINGS DID NOT MATCH ANY DAY OF THE PROVIDED PRESCRIPTION, IN SOME CASES, STRUTS WERE OFF BY OVER 20MM (STRUTS 3&4). THE PATIENT HAD THE TAYLOR SPATIAL FRAME REMOVED ON (B)(6) 2022, NO LONG TERM HARM WAS REPORTED. IT IS UNKNOWN IF ADDITIONAL TREATMENT IS NECESSARY, BUT THE PATIENT HAS REFUSED FURTHER SURGERY.

  Patient problems: Pain

  MAUDE report 16383395 ↗
• MalfunctionAug 17, 2022Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT, AT THE MOMENT OF TRYING TO IMPORT AN X-RAY ((B)(4)) INTO THE SMART TSF SOFTWARE, AND HAVE THE SOFTWARE DETECT THE BEACON ON THE LATERAL VIEW, THE SOFTWARE DID NOT RECOGNIZED THE IMAGE. IT WAS CROPPED THE ANTERIOR PART OF THE IMAGE AWAY ((B)(4)), AND IT WAS ABLE TO GET THE SOFTWARE TO FIND THE BEACON IN THE SMART TSF ACCOUNT. UNFORTUNATELY, THIS IMAGE DID NOT WORK FOR THE PHYSICIAN. SURGEON COMPLAINED ABOUT WASTED TIME (3HR) IN CLINIC, AND UNWANTED RADIATION EXPOSURE TO THE PATIENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15241956 ↗
• InjuryAug 16, 2022Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, THE PHYSICIAN WAS TRYING TO PROGRAM IN THE SMART TSF.COM A PROXIMAL REFERENCE CASE AFTER BUILDING A FRAME WITH A SHORT PROXIMAL RING BLOCK. THE PHYSICIAN SAW 4 DOTS IN 3 ARMS OF THE BEACON, BUT THE SOFTWARE COULD NOT DETECT THE BEACON. PHYSICIAN DECIDED TO USE THE MANUAL MODE INSTEAD. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15236899 ↗