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Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 (REF 50-10400)Recalls & reported problems

Orthofix Srl · LONG STRUT TL-HEX - 158MM-318MM · Class 2

Adverse event reports
14
Deaths reported
0
Injuries reported
10
Recalls naming it
0

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 18054242510673), received between Dec 14, 2017 and Oct 7, 2025 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (14 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 4 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem14
  • Detachment of Device or Device Component4

Patient problems

  • No Clinical Signs, Symptoms or Conditions6
  • Nonunion/Delayed-union Bone Fracture4
  • No Known Impact Or Consequence To Patient3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • No Code Available2
  • Pain1

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 7, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    RECEIVED INFORMATION STATING THAT DURING TREATMENT FOUR (4) STRUTS WERE REPORTED AS FAULTY. PATIENT UNDERWENT A REVISION PROCEDURE. AS PER THE REPORTER THE PATIENT WAS DISCHARGED AND IS RECOVERING.

    Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

    MAUDE report 23232599 ↗
  • MalfunctionOct 7, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    RECEIVED INFORMATION STATING THAT DURING TREATMENT FOUR (4) STRUTS WERE REPORTED AS FAULTY. PATIENT UNDERWENT A REVISION PROCEDURE. AS PER THE REPORTER THE PATIENT WAS DISCHARGED AND IS RECOVERING.

    Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

    MAUDE report 23232583 ↗
  • MalfunctionOct 7, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    RECEIVED INFORMATION STATING THAT DURING TREATMENT FOUR (4) STRUTS WERE REPORTED AS FAULTY. PATIENT UNDERWENT A REVISION PROCEDURE. AS PER THE REPORTER THE PATIENT WAS DISCHARGED AND IS RECOVERING.

    Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

    MAUDE report 23232569 ↗
  • MalfunctionOct 7, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    RECEIVED INFORMATION STATING THAT DURING TREATMENT FOUR (4) STRUTS WERE REPORTED AS FAULTY. PATIENT UNDERWENT A REVISION PROCEDURE. AS PER THE REPORTER THE PATIENT WAS DISCHARGED AND IS RECOVERING.

    Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

    MAUDE report 23232558 ↗
  • InjuryMay 25, 2021Mechanical Problem; Mechanical Problem

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 50-10300 (MEDIUM STRUT TL-HEX - 114MM-184MM) AND 50-10400 ((LONG STRUT TL-HEX - 158MM-318MM). BATCH NUMBER: B1452665 (CODE 50-10300) AND B1405090 (CODE 50-10400) AND B1406264 (CODE 50-10400). QUANTITY: 3 (MFR REPORTS 9680825-2021-00044 AND 9680825-2021-00046). PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THROUGHOUT THE COURSE OF THE HEX PROGRAMME, 3 X MOUNTING CAPS DISLODGED RESULTING IN THE MOUNTING STUDS LOSING LOCKING ABILITY BETWEEN THE RING AND THE HEX STRUTS. FRAME INSTABILITY HAS EXPERIENCED". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION). THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITION: FRACTURE REDUCED AND ALIGNMENT ACQUIRED. MANUFA

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 11874916 ↗
  • InjuryMay 25, 2021Mechanical Problem; Mechanical Problem

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 50-10300 (MEDIUM STRUT TL-HEX - 114MM-184MM) AND 50-10400 ((LONG STRUT TL-HEX - 158MM-318MM). BATCH NUMBER: B1452665 (CODE 50-10300) AND B1405090 (CODE 50-10400) AND B1406264 (CODE 50-10400). QUANTITY: 3 (MFR REPORTS 9680825-2021-00044 AND 9680825-2021-00045). PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THROUGHOUT THE COURSE OF THE HEX PROGRAMME, 3 X MOUNTING CAPS DISLODGED RESULTING IN THE MOUNTING STUDS LOSING LOCKING ABILITY BETWEEN THE RING AND THE HEX STRUTS. FRAME INSTABILITY HAS EXPERIENCED." THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION). THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITION: FRACTURE REDUCED AND ALIGNMENT ACQUIRED. MANUFA

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 11874915 ↗
  • InjuryApr 22, 2021Mechanical Problem; Mechanical Problem

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: DISTAL TIBIA. SURGERY DESCRIPTION: CORRECTION. PATIENT'S INFORMATION: 19 YEAR-OLD, MALE, WEIGHT 85 KG., HEIGHT 180 CM, PREVIOUS HEALTH. CONDITION: GOOD. PROBLEM OBSERVED DURING TREATMENT. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: LOOSENING OF THE TIGHTENING NUT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF ACHIEVED CORRECTION. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: PERFORMED ON (B)(6) 2021. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE (RECEIVED ON (B)(6) 2021). PATIENT CURRENT HEALTH CONDITIONS: GOOD, BUT DELAY OF 10 DAYS IN HEALING DUE TO LOST CORRECTION. FURTHER INFORMATION RECEIVED FROM THE LOCAL DISTRIBUTOR ON 10TH MARCH 2021: THE TWO STRUTS WERE REPLACED AT OUTPATIENT CLINIC WITH NO ANAESTHESIA; THE TIGHTENING NUT OF THE STRUTS DID NOT BR

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11705122 ↗
  • InjuryApr 22, 2021Mechanical Problem; Mechanical Problem

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: -DATE OF INITIAL SURGERY: (B)(6) 2021. -BODY PART TO WHICH DEVICE WAS APPLIED: DISTAL TIBIA. -SURGERY DESCRIPTION: CORRECTION. -PATIENT'S INFORMATION: 19 YEAR-OLD, MALE, WEIGHT 85 KG., HEIGHT 180 CM, PREVIOUS HEALTH CONDITION: GOOD. -PROBLEM OBSERVED DURING TREATMENT: -TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: LOOSENING OF THE TIGHTENING NUT. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF ACHIEVED CORRECTION. - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: PERFORMED ON (B)(6) 2021. - COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE AVAILABLE (RECEIVED ON (B)(6) 2021). - PATIENT CURRENT HEALTH CONDITIONS: GOOD, BUT DELAY OF 10 DAYS IN HEALING DUE TO LOST CORRECTION. FURTHER INFORMATION RECEIVED FROM THE LOCAL DISTRIBUTOR ON 19TH MARCH 2021: -THE TWO STRUTS WERE REPLACED AT OUTPATIENT CLINIC WITH NO ANAESTHESIA. -THE TIGHTENING NUT O

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11705121 ↗
  • InjuryMar 10, 2020Mechanical Problem; Mechanical Problem

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: "MR. (B)(6) HAS HAD THE BELOW ISSUE THREE TIMES IN THE PAST FEW WEEKS. ALL WITH DIFFERENT PATIENTS AND ALL HAVE CAUSED THE FRAMES TO MOVE POSITION SLIGHTLY. THE SMALL BLACK DISC ON THE STRUTS HAVE ALL UNSCREWED AND HAVE BEEN LOST". (ORTHOFIX SRL REF: (B)(4). MFR REPORTS NUMBER 9680825-2020-00023 AND 9680825-2020-00024 AND 9680825-2020-025). ON (B)(6) 2020, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE TERRITORY MANAGER AGAINST THE REQUEST TO RECEIVE A COMPLETED COMPLAINT FORM, ONE FOR EACH PATIENT, FOR THE THREE EVENTS OCCURRED WITH MR (B)(6). "I HAVE SPOKEN TO MR. (B)(6) AND UNFORTUNATELY HE CAN'T PROVIDE ENOUGH INFORMATION TO COMPLETE THE COMPLAINT FORMS. HE INFORMED ME THAT IT HAS HAPPENED 3 OR 4 TIMES BUT COULDN'T TRACE BACK THE PATIENTS INFORMATION, INITIAL SURGERY DATES, ANY DELAYS, WHEN THE FAULT OCCURRED ETC. HE DOES FRAMES IN SUCH HIGH NUMBERS AND SEES SO MANY IN CLINIC THAT THESE DETAILS SIMPLY AREN'T AVAILABLE. I CAN COMPLETE A COMPLAINT FORM FOR THE IMPLANT THAT I HAVE IN MY POSSESSION BUT UNFORTUNATELY COULD NOT COMPLETE A SECOND FORM". ON (B)(6) 2020, ORTHOFIX SRL RECEIVED THE

    Patient problems: No Code Available

    MAUDE report 9811437 ↗
  • InjuryFeb 10, 2020Mechanical Problem; Mechanical Problem

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: PROF. DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT TIBIA. SURGERY DESCRIPTION: CORRECTION, BONE TRANSPORT. PATIENT'S INFORMATION: (B)(6) YEAR-OLD, MALE, WEIGHT (B)(6) KG., HEIGHT 175 CM, PREVIOUS HEALTH CONDITION: HEALTHY. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: IN 2 STRUTS BALL JOINT CAME LOOSE; IN 1 STRUT DETACHMENT OF THE PLASTIC LOCKING INSERT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL 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 NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE. PATIENT CURRENT HEALTH CONDITIONS: (B)(6) 2019 INITIAL SURGERY > (B)(6) 2020 TREATMENT OF INFECTION > (B)(6) 2020 READY FOR (BONE) TRANSPORT. OVERALL, THE BROKEN STRUTS DID NOT HAVE

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9686983 ↗
  • InjuryFeb 10, 2020Mechanical Problem; Mechanical Problem

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: PROF. DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT TIBIA. SURGERY DESCRIPTION: CORRECTION, BONE TRANSPORT. PATIENT'S INFORMATION: (B)(6) YEAR-OLD, MALE, WEIGHT (B)(6) KG., HEIGHT 175 CM, PREVIOUS HEALTH CONDITION: HEALTHY. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: IN 2 STRUTS BALL JOINT CAME LOOSE; IN 1 STRUT DETACHMENT OF THE PLASTIC LOCKING INSERT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL 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 NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE. PATIENT CURRENT HEALTH CONDITIONS: (B)(6) 2019 INITIAL SURGERY > (B)(6) 2020 TREATMENT OF INFECTION > (B)(6) 2020 READY FOR (BONE) TRANSPORT. OVERALL, THE BROKEN STRUTS DID NOT HAVE

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9686958 ↗
  • InjuryFeb 10, 2020Mechanical Problem; Mechanical Problem

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: PROF. DR.(B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT TIBIA. SURGERY DESCRIPTION: CORRECTION, BONE TRANSPORT. PATIENT'S INFORMATION: (B)(6) YEAR OLD, MALE, WEIGHT (B)(6), HEIGHT 175 CM, PREVIOUS HEALTH CONDITION: HEALTHY. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: IN 2 STRUTS BALL JOINT CAME LOOSE; IN 1 STRUT DETACHMENT OF THE PLASTIC LOCKING INSERT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL 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 NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE. PATIENT CURRENT HEALTH CONDITIONS: (B)(6) 2019 INITIAL SURGERY > (B)(6) 2020 TREATMENT OF INFECTION > (B)(6) 2020 READY FOR (BONE) TRANSPORT. OVERALL, THE BROKEN STRUTS DID NOT HAVE AN E

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9686908 ↗
  • InjuryFeb 10, 2020Mechanical Problem; Mechanical Problem

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: (B)(6) YEAR OLD, MALE, WEIGHT APPROX. (B)(6), HEIGHT APPROX. 178CM. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: STRUT CAME LOOSE AT HOME AND BLACK COVER ON ITEM CODE (50-10400) WAS LOOSE WHEN HE WOKE UP ONE MORNING. A SECOND STRUT CAME LOOSE SOME WEEKS LATER, IN SIMILAR FASHION. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE INITIAL 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 NOT REQUIRED: REVISION SURGERY CONSIDERED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: PATIENT STILL HAS FRAME AND IN MIDDLE OF TREATMENT, STRUTS WERE REPLACED.

    Patient problems: Pain

    MAUDE report 9686283 ↗
  • InjuryDec 14, 2017Mechanical Problem; Mechanical Problem

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: (B)(6). DATE OF SURGERY: (B)(6) 2017. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: OTHER. PATIENT INFORMATION: MALE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "DURING LENGTHENING 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, DESPITE THE REGULAR SCREWING OF THIS PIECE. 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, AND COME IN A HURRY TO HAVE HIS STRUT CHANGE". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION) THE INITIAL 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 NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. P

    Patient problems: No Code Available

    MAUDE report 7116342 ↗

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

Other Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.