Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 (REF 50-10170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18054242510161), received between Apr 9, 2021 and May 31, 2021 — classified as 3 injuries.

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

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

• InjuryMay 31, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: 49 YEAR-OLD, MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: CONSTRUCT STRUTS BROKE DURING THE CONSTRUCTION OF THE FRAME, ALL STRUTS WHERE STILL LOOSE WITH NO TENSION APPLIED WHEN THEY DISMANTLED. TWO STUD BALL JOINTS PULLED OUT OF THE SOCKET. THE MALE SIDE OF THE STRUTS CAME UNDONE. PATIENT WOULD HAVE RECEIVED A STACK FRAME WITH 6 HEX STRUTS ON THE ONE RING BLOCK AND 4 RAPID ADJUST STRUTS ON THE SECOND RING BLOCK. THE FRAME THEN HAD TO BE CHANGED FROM A 4 RAPID ADJUST STRUT RING BLOCK TO A 6 HEX STRUT RING BLOCK. MALE SIDE CAME UNDONE. 50% OF THE FRAME WAS ALREADY WITH HEX STRUTS BUT DUE TO FAILURE OF THE RAPID ADJUST STUTS THE FRAM HAD TO BE CONVERTED TO 100% HEX FRAME. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. - A REPLACEMENT DEVICE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907216 ↗
• InjuryMay 31, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR(B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: 49 YEAR-OLD, MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: CONSTRUCT STRUTS BROKE DURING THE CONSTRUCTION OF THE FRAME, ALL STRUTS WHERE STILL LOOSE WITH NO TENSION APPLIED WHEN THEY DISMANTLED. TWO STUD BALL JOINTS PULLED OUT OF THE SOCKET. THE MALE SIDE OF THE STRUTS CAME UNDONE. PATIENT WOULD HAVE RECEIVED A STACK FRAME WITH 6 HEX STRUTS ON THE ONE RING BLOCK AND 4 RAPID ADJUST STRUTS ON THE SECOND RING BLOCK. THE FRAME THEN HAD TO BE CHANGED FROM A 4 RAPID ADJUST STRUT RING BLOCK TO A 6 HEX STRUT RING BLOCK. MALE SIDE CAME UNDONE. 50% OF THE FRAME WAS ALREADY WITH HEX STRUTS BUT DUE TO FAILURE OF THE RAPID ADJUST STUTS THE FRAM HAD TO BE CONVERTED TO 100% HEX FRAME. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT; - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE; - A REPLACEMENT DEVICE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907215 ↗
• InjuryApr 9, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: CROSS ANKLE. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: 42 YEAR-OLD, MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: 4TH STRUT BROKE DURING APPLICATION OF THE STRUT ONTO THE FRAME. HAD TO RECONFIGURE FRAME FROM A 4 TO 3 STRUT CONFIGURATION. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF FRACTURE REDUCTION/LOSS OF ACHIEVED CORRECTION. - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE: THE FRAME WAS BUILT TO USE FOUR STRUTS AND HAD TO BE RECONFIGURED TO USE THREE STRUTS. - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - A MEDICAL INTERVENTION WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. - PATIENT CURRENT HEALTH CONDITIONS: N/A. FURTHER INFORMATION RECEIVED ON MARCH 29, 2021 FROM THE LOCAL DISTRIBUTOR: -DETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640543 ↗

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