Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 (REF 99-56-22020)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18054242512592), received between Dec 16, 2016 and Dec 13, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 30, 2018Class IITerminated

   The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manufactured after September 2016. The firm determined that certain batches of the double row footplates are not compatible with the current version of the TL-HEX struts.

   Z-2063-2018 · Root cause: Device Design · Recall details · FDA record ↗

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.

• InjuryDec 13, 2017Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2017. - BODY PART TO WHICH DEVICE WAS APPLIED: FOOT. - SURGERY DESCRIPTION: NA. - PATIENT INFORMATION: FEMALE. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: "DURING THE SURGERY, (B)(6) DECIDE TO PUT A DOUBLE FOOT PLATE RING TO FINISH THE FRAME HE MADE ON THE TIBIA. HE PUT ALL THE WIRE, TENSE THEM, CUT THEM, AND WHEN HE START TO PUT THE STRUT INTO THE HOLE, NOT A SINGLE HOLE FIT. THE HOLES WERE TOO TIGHT. I WAS IN THE TEATHER. SO AS HE HAD SAFETY KIT, HE PUTS 3 OF THEM IN ORDER TO REPLACE THE FAILING HOLES." THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS COMPLETED WITH DEVICE. - THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. - PATIENT CURRENT HEALTH CONDITION: NA. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7112791 ↗
• InjuryDec 16, 2016Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICE CODE: 99-56-22020; LOT NUMBER: V1374298; QUANTITY: 1; HOSPITAL NAME: NOT PROVIDED; SURGEON NAME: NOT PROVIDED; DATE OF INITIAL SURGERY: (B)(6) 2016; BODY PART TO WHICH DEVICE WAS APPLIED: NOT PROVIDED; SURGERY DESCRIPTION:NOT PROVIDED; PATIENT'S INFORMATION: NOT PROVIDED; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: AS THE DAY PROGRESSES WE HAVE ENCOUNTERED THE SAME ISSUE IN ANOTHER HOSPITAL. HOLES FOR THE NEW STRUTS ARE TOO SMALL. NEW STRUTS DO NOT FIT. SAME SIZE OF THE DOUBLE ROW TL-HEX FOOT PLATE 140MM, LOT V1374298. ON 18 NOVEMBER ORTHOFIX (B)(4) RECEIVED FROM THE DISTRIBUTOR TWO PICTURES ILLUSTRATING THE FUNCTIONAL PROBLEM NOTIFIED. ON JANUARY 24, 2017 ORTHOFIX (B)(4) RECEIVED FROM THE DISTRIBUTOR THE COMPLETED COMPLAINT FORM, INCLUDING THE FOLLOWING DETAILS, WHICH WERE NOT PROVIDED WITH THE INITIAL NOTIFICATION: PROBLEM OBSERVED DURING: REP'S INVENTORY INSPECTION; THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT: THE FOOT PLATE WAS REMOVED FROM OPERATING THEATRE BEFORE SURGERY STARTED; THE EVENT DID NOT

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6180095 ↗
• InjuryDec 16, 2016Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICE CODE: 99-56-22020; LOT NUMBER: V1374298; QUANTITY: 1; HOSPITAL NAME: NOT PROVIDED; SURGEON NAME: NOT PROVIDED; DATE OF INITIAL SURGERY: (B)(6) 2016; BODY PART TO WHICH DEVICE WAS APPLIED: NOT PROVIDED; SURGERY DESCRIPTION:NOT PROVIDED; PATIENT'S INFORMATION: NOT PROVIDED; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: SURGEON DECIDED TO DO A BUTT FRAME AND USED 140 MM DOUBLE ROW FOOT PLATE. WHEN HE TRIED TO CONNECT RINGS WITH TL-HEX STRUTS, THE FOOT PLATE WOULD NOT ACCEPT THE NEW STYLE OF STRUTS. THE HOLES FOR THE PEGS WERE TO SMALL. HE HAD NO ISSUE PUSHING IN THE OLD STYLE OF TL-HEX STRUTS. THE FRAME IS CURRENTLY ON THE PATIENT, RINGS CONNECTED WITH RAPID ADJUST STRUTS. WE ARE SENDING THE REMAINDER OF OLD STRUTS FROM OUR WAREHOUSE TO THE HOSPITAL FOR MONDAY CONVERSION TO TL-HEX FRAME. ON 18 NOVEMBER ORTHOFIX (B)(4) RECEIVED FROM THE DISTRIBUTOR TWO PICTURES ILLUSTRATING THE FUNCTIONAL PROBLEM NOTIFIED. ON JANUARY 24, 2017 ORTHOFIX (B)(4) RECEIVED FROM THE DISTRIBUTOR THE COMPLETED COMPLAINT FORM, INCLUDING THE FOLLOWING DETA

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6180084 ↗