ORTHOFIX MODULSYSTEMRecalls & reported problems across all models
Orthofix Srl · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one ORTHOFIX MODULSYSTEM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 4
We found 15 models of ORTHOFIX MODULSYSTEM by Orthofix Srl in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between May 29, 2018 and Dec 16, 2025 — classified as 10 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (7 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ORTHOFIX MODULSYSTEM recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 10, 2026Open, Classified
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Z-2732-2026 · Root cause: Process change control · Recall details · FDA record ↗
- Jun 10, 2026Open, Classified
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Z-2731-2026 · Root cause: Process change control · Recall details · FDA record ↗
- Jun 10, 2026Open, Classified
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Z-2730-2026 · Root cause: Process change control · Recall details · FDA record ↗
- Jun 10, 2026Open, Classified
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Z-2729-2026 · Root cause: Process change control · Recall details · FDA record ↗
Most reported ORTHOFIX MODULSYSTEM problems
Device problems
- Mechanical Problem7
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
- Fracture1
- Insufficient Device Problem Information1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Code Available3
- Insufficient Information2
- Device Embedded In Tissue or Plaque1
- Failure of Implant1
- Post Operative Wound Infection1
ORTHOFIX MODULSYSTEM models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 recall2 reports
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Pin, Fixation, Threaded1 report
Recent ORTHOFIX MODULSYSTEM adverse event reports
The 13 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS PER THE REPORTER, DURING THE SURGICAL PROCEDURE, THEY EXPERIENCED A DISASSEMBLING OF COMPONENTS OF THE DEVICE. THIS CAUSED A SURGICAL DELAY OF 30 MINUTES DUE TO THE DEVICE REPLACEMENT. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815333 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RECEIVED INFORMATION STATING THAT AN LRS ADV KIT WAS DELIVERED INCOMPLETE. AS PER REPORTER, THE SURGICAL PROCEDURE WAS COMPLETED USING OTHER ITEMS INCLUDED IN THE KIT, LEADING TO A PROLONGATION OF THE SURGERY BY 45 MINUTES. AS PER THE REPORTER, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23691661 ↗InjuryOct 15, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT A PATIENT HAD AN ACCIDENTAL IMPACT WITH A FAMILY MEMBER (OLDER SIBLING) WHICH RESULTED IN A KNOCK/FALL. THE IMPACT OF THIS APPEARS TO HAVE CAUSED THE LOCKING MECHANISM OF THE FIXATOR TO MALFUNCTION. THE FIXATOR HAS BEEN REMOVED.
Patient problems: Insufficient Information
MAUDE report 23298375 ↗InjuryFeb 6, 2025Mechanical Problem; Mechanical Problem
THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6), SURGEON'S NAME: DR. (B)(6), DATE OF INITIAL SURGERY: ON (B)(6) 2024, BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT ULNA, SURGERY DESCRIPTION: ULNA LENGTHENING, PATIENT INFORMATION: 21-YEAR-OLD, FEMALE, PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: FAMILY STATED RAIL FELL OFF AT HOME DURING LENGTHENING. RAIL AND PINS DO NOT LOOK COMPROMISED. ANOTHER SURGERY WILL NEED TO BE PERFORMED. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF LENGTH AND 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 IS REQUIRED: TO BE DEFINED A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: PERFORMED ON (B)(6) 2025. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE THE DEVICE WAS AT ITS FIRST USE PATIENT CURRENT HEALTH CONDITION: N/A MANUFACTURER REFERENCE NUMBER: (B)(4) DISTRIBUTOR REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21322936 ↗InjuryFeb 6, 2025Mechanical Problem; Mechanical Problem
THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6), SURGEON'S NAME: DR. (B)(6), DATE OF INITIAL SURGERY: (B)(6), 2024 BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT ULNA, SURGERY DESCRIPTION: ULNA LENGTHENING, PATIENT INFORMATION: 21-YEAR-OLD, FEMALE, PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: FAMILY STATED RAIL FELL OFF AT HOME DURING LENGTHENING. RAIL AND PINS DO NOT LOOK COMPROMISED. ANOTHER SURGERY WILL NEED TO BE PERFORMED. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF LENGTH AND 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 IS REQUIRED: TO BE DEFINED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: PERFORMED ON (B)(6) 2025. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. THE DEVICE WAS AT ITS FIRST USE. PATIENT CURRENT HEALTH CONDITION: PINS OF THE MINIRAIL WERE REMOVED AND PATIENT HAD INTERNAL FIXATION AND BONE GRAFT. MANUFACTURER REFERENCE NUMBER: (B)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21320392 ↗MalfunctionNov 27, 2024Mechanical Problem; Mechanical Problem
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: EVENT NOTIFIED BY THE HOSPITAL TO ANSM; ANSM REF: (B)(4). HOSPITAL NAME: (B)(6). CORRESPONDENT DE VIGILANCE: MADAME (B)(6). DEVICE CODE: 99-91647UE. DEVICE LOT: B4856633. DATE OF SURGERY: ON (B)(6) 2024. DATE OF EVENT: 08/11/2024. EVENT DESCRIPTION: VIS SERVENT AU MAINTIEN DU MÉCANISME (AU BIVEAU DE LA STRUCTURE POUR VERROUILLER LA POSITION) NON FONCTIONNEL, LA POSITION NE SE BLOQUE PAS PATIENT CURRENT CONDITION: RALLONGEMENT DU TEMPS OPÉRATOIRE DE 2H POUR RÉCUPÉRER UN FIXATEUR EXTERNE AUPRÈS D'UN AUTRE ÉTABLISSEMENT. SURVEILLANCE SIMPLE À CE JOUR, PRÉLÈVEMENT BACTÉRIO NÉGATIFS LE 19/11 ACTION TAKEN: DÉPANNAGE D'UN DISPOSITIF DE REMPLACEMENT AUPRÈS D'UN AUTRE ÉTABLISSEMENT. ON NOVEMBER 22, 2024, ORTHOFIX SRL RECEIVED INFORMATION THAT THE HOSPITAL DISCARDED THE COMPLAINED DEVICE. ON NOVEMBER 25, 2024, ORTHOFIX RECEIVED THE FOLLOWING ADDITIONAL DETAILS: SURGEON'S NAME: DR. (B)(6). BODY PART TO WHICH DEVICE WAS APPLIED: FRACTURE BIMALEOLAIRE DROITE. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: 80 YEARS, FEMALE, 168 CM, 90 KG. EVENT DESCRIPTION: THERE WAS A PROBLEM WITH THE CENTRAL SCREW, IT WAS SEIZED
Patient problems: Failure of Implant
MAUDE report 20794900 ↗InjuryJun 25, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITALIER DATE OF INITIAL SURGERY: ON (B)(6) 2024 SURGERY DESCRIPTION: FRACTURE TREATMENT PATIENT INFORMATION: MALE PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE TYPE OF PROBLEM: PACKAGING PROBLEM/DEVICE FUNCTIONAL PROBLEM EVENT DESCRIPTION: "INSTALLATION OF AN XCALIBER EXTERNAL FIXATOR HYBRID IN A PATIENT ASLEEP IN THE ROOM OF OPERATION. TRANSPARENT FILM IN PLACE, CARDBOARD BOX IN VERY GOOD STATE. OPENING THE BOX TO GIVE IT TO THE IDE INSTRUMENTALIST. THE PLASTIC PREFORMED IS COMPLETELY DEFORMED (MELTED?), THE WHITE COVER ON THE ABOVE IS NOT AIRTIGHT AND THEREFORE NOT STERILE. DECISION WITH THE SURGEON TO OPEN THE SECOND PACKAGING (SECOND PREFORMED PLASTIC), WHICH IS ALSO MELTED BUT AIRTIGHT. NO SECOND STERILE KIT AVAILABLE IN THE OPERATING ROOM DECISION OF USE OF DM WITH DOUBT ABOUT STERILITY. ADVERSE EFFECTS: APPEARANCE OF SKIN PAIN WITH AREA OF NECROSIS AND EXPOSURE OF THE BONE. BACK TO THE BLOCK OPERATION ON (B)(6) 2024 FOR DEBRIDEMENT AND INSTALLATION OF A VAC THERAPY AND ABLATION SCREW AND PLUG AND BONE GRAFT. BACTERIOLOGICAL SAMPLING (BONES, ROUTE SHEET) POSITIVE FOR
Patient problems: Post Operative Wound Infection
MAUDE report 19603409 ↗MalfunctionMay 26, 2023Mechanical Problem; Mechanical Problem
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99-36501. BATCH NUMBER: B1845741. HOSPITAL NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6), 2023. BODY PART TO WHICH DEVICE WAS APPLIED: WRIST. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: 60 YEARS, FEMALE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. EVENT DESCRIPTION: DEVICE BREAKAGE INTO TREATMENT. THE COMPLAINT REPORT FORM ALSO INDICATES: 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 REQUIRED (PERFORMED ON (B)(6), 2023). A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. PRODUCT IS AVAILABLE FOR RETURN. PRODUCT HAS BEEN PROPERLY CLEANED AND DISINFECTED. ON MAY 24, 2023, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE LOCAL DISTRIBUTOR: NAME OF THE SURGEON: DR. (B)(6). DATE OF THE BREAKAGE OF THE DEVICE: (B)(6) 2023. CIRCUMSTANCES OF THE FAILURE (WHAT WAS DOING THE PATIENT AT THE MOMENT OF THE DEVICE FAILURE?): NOTHING, THE KNEECAP CAME LOOSE. NO ADVERSE EFFECTS ON PATIENT. DURING THE REVISION SURGERY THE FIXATOR WAS REMOVED, NO OTHER DEV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17008757 ↗InjuryNov 12, 2020Mechanical Problem; Mechanical Problem
ON OCTOBER 15, 2020, ORTHOFIX SRL RECEIVED AN XCALIBER KIT TOGETHER WITH A COMPLAINT FORM WHICH INCLUDED THE FOLLOWING INFORMATION: HOSPITAL NAME: (B)(6). SURGEON NAME: DR.(B)(6). DATA OF SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT TIBIA. PATIENT INFORMATION: 25 YEARS, MALE, 90 KG, 180 CM. DATE OF SURGERY: FRACTURE TREATMENT. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "IN THE FIRST 7 DAYS THERE WAS A FAILURE OF THE DEVICE (PROXIMAL PART) WITH FRACTURE DISPLACEMENT AND NEED FOR A SECOND SURGERY ((B)(6) 2020.)". THE COMPLAINT REPORT FORM INCLUDED ALSO COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES. NO OTHER INFORMATION WAS GIVEN. MANUFACTURER REFERENCE NUMBER: (B)(4).
Patient problems: Insufficient Information
MAUDE report 10828669 ↗InjuryJan 9, 2020Break; Break
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) GENERAL HOSPITAL. SURGEON NAME: DR (B)(6). DATE OF SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: UNKNOWN. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: THE 260/40 SCHANZ PIN BROKE DOWN WHILE INSERTING IN THE FEMUR. PREDRILLING WAS DONE ALREADY. THE PIN WAS TOO TIGHT TO INSERT. THEN IT GOT BENT. WHILE RETRIEVING THE PIN, IT BROKE DOWN. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: UN-RETRIEVED DEVICE FRAGMENTS. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE. PATIENT CURRENT HEALTH CONDITION: UNKNOWN. MANUFACTURER REFERENCE NUMBER: (B)(4).
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9568638 ↗InjuryDec 10, 2018Mechanical Problem; Mechanical Problem
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: M511 (M2 MULTIPLANAR MINIRAIL) - BATCH NUMBER: UNKNOWN - QUANTITY: 1 - HOSPITAL NAME: (B)(6) HOSPITAL; - SURGEON NAME: DR (B)(6); - DATE OF INITIAL SURGERY: (B)(6) 2018; - BODY PART TO WHICH DEVICE WAS APPLIED: NO RESPONSE; - SURGERY DESCRIPTION: CORRECTION; - PATIENT INFORMATION: NO RESPONSE; - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE; - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; - EVENT DESCRIPTION: "PER REP SURGEON DID A CASE IN (B)(6) ON A PATIENT BACK IN (B)(6) OF THIS YEAR. THE PATIENT WAS IN (B)(6) AND HAD AN ISSUE WITH SOMETHING ON THE FRAME BEING LOOSE. THE LOCAL REP, WAS ASKED TO GO AND LOOK AT THE FRAME. THE M511 WAS LOOSE AND SO TM TOOK ONE OF THE SCREWS AND TRIED TO USE THAT TO TIGHTEN THE M511 WHICH WAS ON THE PATIENT CURRENTLY. WHEN THE PATIENT GOT BACK TO (B)(6), HE WENT BACK TO SURGEON AND THEY TOOK THE FRAME OFF AND PUT ON ANOTHER ONE. THE FRAME WAS REPLACED THIS PAST MONDAY OR TUESDAY. PER REP, THE PATIENT WAS SEDATED AND THE M511 WAS REPLACED IN A PROCEDURE ROOM". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PA
Patient problems: No Code Available
MAUDE report 8145722 ↗InjurySep 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICE CODE: 99-91245. BATCH NUMBER: B1237875. QUANTITY: 1. HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR (B)(6). DATE OF SURGERY: (B)(6) 2018. BODY PART TO WHICH DEVICE WAS APPLIED: ANKLE. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: NO RESPONSE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "BY THE (B)(6) 2018, PATIENT HAS BEEN TREATED FOR AN EXTERNAL FIXATOR ON RIGHT ANKLE. BY THE (B)(6) 2018, HE CAME BACK BECAUSE FIXATOR GOT DISADAPTED". THE COMPLAINT REPORT FORM ALSO INDICATES: THE SURGERY WAS COMPLETED WITH THE DEVICE. 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 REQUIRED. NO OTHER INFORMATION WAS PROVIDED. (B)(4).
Patient problems: No Code Available
MAUDE report 7849899 ↗InjuryMay 29, 2018Fracture; Fracture
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) MEDICAL CENTER - SURGEON'S NAME: DR. (B)(6) - DATE OF INITIAL SURGERY:(B)(6) 2018 - BODY PART TO WHICH DEVICE WAS APPLIED: ANKLE - SURGERY DESCRIPTION: ANKLE FIXATOR - PATIENT INFORMATION: (B)(6), MALE - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: DR. (B)(6) DID A REVISION TO TIGHTEN A SCREW THAT WAS COMING LOOSE AND HE AND THE REP NOTICED A CRACK IN THE DEVICE. IT WAS REMOVED AND NOT REPLACED HAD NOTHING TO DO WITH THE DEVICE FAILURE. IT WAS NOTICED DURING THE REVISION. SURGERY DESCRIPTION: ANKLE FIXATOR. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT - 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 NOT REQUIRED - 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: UNKNOWN. FURTHER INFORMATION RECEIVED FROM THE DIS
Patient problems: No Code Available
MAUDE report 7548312 ↗
Other Orthofix Srl products
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM140 models · 5 reports · 20 recalls
- Orthofix TrueLok Hexapod System (TL-HEX) V2.015 models · 45 reports · 1 recall
- ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT2 models · 2 reports · 1 recall
- Galaxy Unyco4 models · 0 reports · 1 recall
- FITBONE TAA SYSTEM10 models · 32 reports
- CHIMAERA Hip Fracture System16 models · 30 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page