Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 (REF 50-10180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 18054242510178), received between Oct 3, 2018 and Oct 22, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE TWO STRUTS DISASSEMBLED FROM THE FRAME AND COULD NOT BE RECONNECTED. THE SURGICAL PROCEDURE WAS COMPLETED USING REPLACEMENT DEVICES IMMEDIATELY AVAILABLE. AS PER REPORTED, THIS CAUSED A DELAY OF 30-45 MINUTES, NO ADVERSE EFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358042 ↗
• MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE TWO STRUTS DISASSEMBLED FROM THE FRAME AND COULD NOT BE RECONNECTED. THE SURGICAL PROCEDURE WAS COMPLETED USING REPLACEMENT DEVICES IMMEDIATELY AVAILABLE. AS PER REPORTED, THIS CAUSED A DELAY OF 30-45 MINUTES, NO ADVERSE EFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357948 ↗
• MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE TWO STRUTS DISASSEMBLED FROM THE FRAME AND COULD NOT BE RECONNECTED. THE SURGICAL PROCEDURE WAS COMPLETED USING REPLACEMENT DEVICES IMMEDIATELY AVAILABLE. AS PER REPORTER, THIS CAUSED A DELAY OF 30-45 MINUTES, NO ADVERSE EFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336392 ↗
• MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE TWO STRUTS DISASSEMBLED FROM THE FRAME AND COULD NOT BE RECONNECTED. THE SURGICAL PROCEDURE WAS COMPLETED USING REPLACEMENT DEVICES IMMEDIATELY AVAILABLE. AS PER REPORTER, THIS CAUSED A DELAY OF 30-45 MINUTES, NO ADVERSE EFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336391 ↗
• InjuryMar 10, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 50-10180 (TRUE LOK PLUS MEDIUM QUICK ADJUST STRUT). BATCH NUMBER: B1390272. QUANTITY: 1. DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: KNEE. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: 86 YEARS, FEMALE, 75 KG, 171 CM. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THE FRAME, AT THE TIME OF THE PROBLEM, WAS COMPOSED BY 2 RINGS AND 2 MEDIUM RAPID STRUTS. THE SURGEON STARTED REDUCING THE FRACTURE WITH THE FRAME. THEY WERE LOCKING ONE RAPID STRUT TO THE PROXIMAL RING, THEN THEY NOTICED THAT THE "HEAD" OF THIS RAPID STRUT WAS COMING OUT OF THE "STRUT BODY" AS THE REDUCING WAS PERFORMED. THE SURGEONS COMPLETED THE FRAME USING 2 STANDARD STRUTS AND, AT THE END OF THE SURGERY, ANOTHER MEDIUM RAPID STRUT WAS USED TO COMPLETE THE FRAME AS ORIGINALLY PLANNED.". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION). THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGI

  Patient problems: Joint Dislocation

  MAUDE report 11451056 ↗
• InjuryOct 25, 2019Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: DR. (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2019; BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT LOWER EXTREMITY, FOOT AND ANKLE; SURGERY DESCRIPTION: CORRECTION; PATIENT INFORMATION: (B)(6) YEAR-OLD, MALE, (B)(6) LBS, 6 FT; PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: PER TERRITORY MANAGER, HE STATES THAT APPROXIMATELY 2 WEEKS AFTER SURGERY, PATIENT CAME INTO CLINIC WITH A BROKEN STRUT (50-10180). PATIENT, ACCORDING TO REP, WAS TO BE NON-WEIGHT BEARING. THE REP ADVISED THAT THE PATIENT REQUIRED ANESTHESIA TO REPLACE BROKEN PINS, NOT TO CHANGE THE BROKEN STRUT. ADDITIONAL INFORMATION: "THE PATIENT WAS DIAGNOSED WITH PLANTAR FOOT ULCER WITH SKIN FLAP. NO X-RAYS OR PHOTOGRAPHS WERE TAKEN. THE TWO BROKEN 54-1215S WERE NOTICED AT THE SAME TIME AS THE BROKEN STRUT. BOTH OF THE PINS WERE COMPLETELY REMOVED AND REPLACED. THE EXPLANTED PINS WERE DISCARDED. THE PATIENT RECEIVED LOCAL ANESTHESIA TO REMOVE THE PINS. THE DISTRIBUTOR ADVISED THAT PATIENT'S CONDITION WAS POSSIBLY DUE TO THE MALFUNCTION OF THE DEVICES. THE PATIEN

  Patient problems: No Code Available

  MAUDE report 9238381 ↗
• InjuryOct 3, 2018Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: (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 7929333 ↗

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