Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 (REF 50-10190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 18054242510185), received between Oct 3, 2018 and Apr 15, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA MIDSHAFT. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: (B)(6) YEAR-OLD, MALE, WEIGHT (B)(6), HEIGHT 1,81, PREVIOUS HEALTH CONDITION: NONE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: THE MALE END (BALL-JOINT) OF THE LONG RAPID ADJUST STRUT FAILED DURING TIGHTENING OF THE STRUT ONTO A HEXAPOD RING. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF FRACTURE REDUCTION. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: THE PROCEDURE DURATION WAS LONGER THAN NECESSARY DUE TO LOSS OF FRACTURE REDUCTION AND THE TIME WE HAD TO SPEND REPLACING THE FAULTY STRUT. 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 HEAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670376 ↗
• InjuryApr 7, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) MEDICLINIC. SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: HUMERUS. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: 58 YEAR-OLD, FEMALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: APPLIED RAPID ADJUST STRUT, COME APART DURING APPLICATION. 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 NOT IMMEDIATELY AVAILABLE TO COMPLETE SURGERY: REDUCED THE NUMBER FROM 4 TO 3 STRUTS. - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: READJUSTMENT OF THE FRAME LAYOUT. - 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 (B)(6), 2021 FROM THE LOCAL DISTRIBUTOR: -DETERMINATION OF THE EXTRA TIME NEEDED TO FINALIZE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627040 ↗
• InjuryMar 12, 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: FEMUR - SURGERY DESCRIPTION: FRACTURE TREATMENT - PATIENT'S INFORMATION: 61 YEAR-OLD, MALE, PREVIOUS HEALTH CONDITION: GOOD. - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: "TWO STRUTS BROKE DURING SURGERY AT HEAD LEVEL." THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: INSTABILITY OF THE FIXATOR - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE - A REPLACEMENT DEVICE WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE SURGERY: I HAD TO COMMAND TWO OTHERS STRUTS AND APPLY THEM ON PATIENT ONE DAY AFTER THE SURGERY - THE EVENT DID NOT LEAD 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 AVAILABLE. - PATIENT CURRENT HEALTH CONDITIONS: NO EFFECT TO PATIENT HEALTH. FURTHER INFORMATION RECEIVED ON FEBRUARY 17,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11468950 ↗
• InjuryMar 12, 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: FEMUR. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: 61 YEAR-OLD, MALE, PREVIOUS HEALTH CONDITION: GOOD. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "TWO STRUTS BROKE DURING SURGERY AT HEAD LEVEL.". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: INSTABILITY OF THE FIXATOR. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE SURGERY: I HAD TO COMMAND TWO OTHERS STRUTS AND APPLY THEM ON PATIENT ONE DAY AFTER THE SURGERY THE EVENT DID NOT LEAD 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 AVAILABLE. PATIENT CURRENT HEALTH CONDITIONS: NO EFFECT TO PATIENT HEALTH. FURTHER INFORMATION RECEIVED ON FEBRUARY 17, 2021 FROM THE LOCAL DISTRIBUTOR:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11468946 ↗
• InjuryMar 2, 2021Break; Break

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6) GENERAL HOSPITAL. - SURGEON NAME: (B)(6) . - DATE OF INITIAL SURGERY: (B)(6) 2021. - BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PATIENT'S INFORMATION: 53 YEAR-OLD, MALE, WEIGHT: 93KG, HEIGHT: 178CM. - PREVIOUS HEALTH CONDITION: SCHIZOPHRENIA, SMOKER, LUDWIG ANGINA. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT AND INTO TREATMENT. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: 3 RAPID STRUTS HAVE FAILED ON A FRAME CAUSING AN ADDITIONAL FRACTURE. FRAME APPLIED TO SPAN ANKLE AFTER PLATING FOR PILON FRACTURE. THERE WAS NO TIBIAL FRACTURE PRESENT, THE FRAME WAS JUST TO PROTECT PILON PLATING. 3 NEW STYLE STRUTS FAILED POST OP, OLD STYLE STRUT WAS FINE. MUM SAYS: INITIALLY THERE WAS 1 STRUT POPPING OUT WHICH HAPPENED A FEW DAYS BEFORE INCIDENT. THEN WHEN HE WAS COMING DOWN THE STAIRS ALL 3 STRUTS POPPED AND HE FELL DOWN THE STAIRS - THIS HAPPENED SUNDAY 7TH FEB. IMMEDIATELY HAD PAIN AND WAS UNABLE TO WEIGHTBEAR. MUM CALLED THE HOSPITAL ON MONDAY 8TH FEB AND DECISION TO SEE AQ IN THE VERY NEXT CLINIC - TUESDAY(B)(6) . GOT XRAYS

  Patient problems: Bone Fracture(s)

  MAUDE report 11397573 ↗
• InjuryMar 2, 2021Break; Break

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: (B)(6) YEAR-OLD, MALE, WEIGHT: (B)(6) KG, HEIGHT: 178CM. PREVIOUS HEALTH CONDITION: SCHIZOPHRENIA, SMOKER, LUDWIG ANGINA. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT AND INTO TREATMENT. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: 3 RAPID STRUTS HAVE FAILED ON A FRAME CAUSING AN ADDITIONAL FRACTURE. FRAME APPLIED TO SPAN ANKLE AFTER PLATING FOR PILON FRACTURE. THERE WAS NO TIBIAL FRACTURE PRESENT, THE FRAME WAS JUST TO PROTECT PILON PLATING. 3 NEW STYLE STRUTS FAILED POST OP, OLD STYLE STRUT WAS FINE. MUM SAYS: INITIALLY THERE WAS 1 STRUT POPPING OUT WHICH HAPPENED A FEW DAYS BEFORE INCIDENT. THEN WHEN HE WAS COMING DOWN THE STAIRS ALL 3 STRUTS POPPED AND HE FELL DOWN THE STAIRS - THIS HAPPENED SUNDAY (B)(6). IMMEDIATELY HAD PAIN AND WAS UNABLE TO WEIGHTBEAR. MUM CALLED THE HOSPITAL ON MONDAY (B)(6) AND DECISION TO SEE AQ IN THE VERY NEXT CLINIC - TUESDAY (B)(6). GOT XRAYS ON TUESDAY WHICH WAS W

  Patient problems: Bone Fracture(s)

  MAUDE report 11397572 ↗
• InjuryMar 2, 2021Break; Break

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: (B)(6), MALE, WEIGHT: (B)(6), HEIGHT: 178CM. PREVIOUS HEALTH CONDITION: SCHIZOPHRENIA, SMOKER, LUDWIG ANGINA. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT AND INTO TREATMENT. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: 3 RAPID STRUTS HAVE FAILED ON A FRAME CAUSING AN ADDITIONAL FRACTURE. FRAME APPLIED TO SPAN ANKLE AFTER PLATING FOR PILON FRACTURE. THERE WAS NO TIBIAL FRACTURE PRESENT, THE FRAME WAS JUST TO PROTECT PILON PLATING. 3 NEW STYLE STRUTS FAILED POST OP, OLD STYLE STRUT WAS FINE. MUM SAYS: INITIALLY THERE WAS 1 STRUT POPPING OUT WHICH HAPPENED A FEW DAYS BEFORE INCIDENT. THEN WHEN HE WAS COMING DOWN THE STAIRS ALL 3 STRUTS POPPED AND HE FELL DOWN THE STAIRS - THIS HAPPENED SUNDAY (B)(6). IMMEDIATELY HAD PAIN AND WAS UNABLE TO WEIGHTBEAR. MUM CALLED THE HOSPITAL ON (B)(6) AND DECISION TO SEE AQ IN THE VERY NEXT CLINIC - TUESDAY (B)(6). GOT XRAYS ON TUESDAY WHICH WAS WHEN AQ RAISED ISSUE WITH ME.

  Patient problems: Bone Fracture(s)

  MAUDE report 11397571 ↗
• InjuryJan 3, 2020Break; Break

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME FOR ORTHOPAEDIC SURGERY: (B)(6). HOSPITAL NAME FOR PLASTIC SURGERY: (B)(6). DATE OF INITIAL SURGERY: UNKNOWN. BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: 70 YEAR-OLD, MALE, PREVIOUS HEALTH CONDITION: UNKNOWN; TRAUMA PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; CLINICAL (PATIENT) PROBLEM EVENT DESCRIPTION: PATIENT WAS OPERATED ON IN (B)(6) HOSPITAL BY (B)(6), WHERE HIS FRACTURE WAS REDUCED. RAPID STRUTS WERE USED ON THE FRAME TO STABILIZE THE FRACTURE AND PATIENT WAS SENT TO (B)(6) HOSPITAL FOR PLASTIC SURGERY INTERVENTION, DURING WHICH A STRUT "POPPED OFF" AND THE SURGICAL STAFF WERE UNABLE TO REPLACE THE STRUT. THE CLINIC NURSE HAD SENT AN UNSTERILE STRUT FOR STABILIZING THE FRAME OVER THE PLASTICS SITE UPON COMPLETION OF THE GRAFT, WHICH THEY USED IN PLACE OF THE FAULTY STRUT. THE PATIENT WAS THEN RETURNED TO CLINIC IN (B)(6) HOSPITAL, WHERE (B)(6)(INITIAL ORTHO SURGEON) ASSESSED THE REMAINING STRUTS AND FOUND A SECOND HAD BROKEN. AT TH

  Patient problems: No Code Available

  MAUDE report 9543453 ↗
• InjuryOct 3, 2018Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6), SURGEON'S NAME: (B)(6), DATE OF SURGERY: (B)(6) 2018, BODY PART TO WHICH DEVICE WAS APPLIED: FOOT, SURGERY DESCRIPTION: CORRECTION, PATIENT INFORMATION: FEMALE, (B)(6), PREVIOUS HEALTH CONDITION: DIABETIC, PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: 2 STRUTS BROKE DURING CORRECTION. SURGEON TOOK OFF THE WHOLE FRAME ON (B)(6) AND DID NOT INDICATE ANY HEALTH ISSUE SO FAR. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF ACHIEVED CORRECTION, THE SURGERY WAS COMPLETED WITH THE DEVICE, THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE, AN ADDITIONAL SURGERY WAS REQUIRED: PERFORMED ON (B)(6) 2018, A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED, COPY OF X-RAY IMAGES AND OPERATIVE REPORTS ARE NOT AVAILABLE. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7929364 ↗

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