Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 (REF 50-10200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18054242510635), received between Feb 1, 2018 and Feb 1, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K170650); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2018Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: (B)(6). DATE OF SURGERY: UNKNOWN, BEGINNING OF THE YEAR 2017. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: LENGTHENING. PATIENT INFORMATION: FEMALE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: NO RESPONSE. EVENT DESCRIPTION: "DURING TREATMENT THE BLACK PART OF THE STRUT, LOCATED AT THE BACK OF THE MOUTHPIECE, ON EACH SIDE OF THE STRUT, LEFT. IT TOOK OFF ALONE. THE PARENTS WHEN (SCARED) AS SOON THEY COULD TO CHANGE THE STRUT. THE BLACK PIECE WAS GONE. RESULT OF IT: THE STRUT WAS NOT FUNCTIONAL AND THEY HAD TO CHANGE FOR A NEW ONE. THE PATIENT HAD TO STOP THE CORRECTION FOR FEW DAYS (THAT WAS ALMOST THE END). AFTER THE CHANGE OF THE STRUT, THE FRAME WAS OK. THE CORRECTION END PROPERLY". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT [CHANGE THE STRUT AND BEING VERY SCARED (FOR THE PARENT) OF THE INSTABILITY OF THE FRAME]; COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE; COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE; PATIENT CURRENT HEALTH CONDITION: GOOD. ON JANUARY 15, 2018, ORTH

  Patient problems: No Code Available

  MAUDE report 7233431 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170650. One submission often covers many models, so check the product and lot details in each record.

• Z-2063-2018 · Jan 30, 2018 · Terminated
  TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of r