VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEMRecalls & reported problems across all models
Orthofix Srl · 140 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 20
We found 140 models of VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM by Orthofix Srl in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Jan 23, 2018 and Apr 17, 2018 — classified as 5 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (5 reports).
20 FDA recall records name at least one of these models by its device identifier.
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
VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 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.
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2135-2018 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2134-2018 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2133-2018 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2132-2018 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2131-2018 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2130-2018 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2129-2018 · Root cause: Device Design · names 8 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2128-2018 · Root cause: Device Design · names 5 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2127-2018 · Root cause: Device Design · names 4 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2126-2018 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2125-2018 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2124-2018 · Root cause: Device Design · names 21 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2123-2018 · Root cause: Device Design · names 21 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2122-2018 · Root cause: Device Design · names 17 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2121-2018 · Root cause: Device Design · names 16 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2120-2018 · Root cause: Device Design · names 12 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2119-2018 · Root cause: Device Design · names 12 of these models · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2118-2018 · Root cause: Device Design · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2117-2018 · Root cause: Device Design · Recall details · FDA record ↗
- Apr 6, 2018Terminated
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Z-2116-2018 · Root cause: Device Design · Recall details · FDA record ↗
Most reported VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM problems
Device problems
- Mechanical Problem5
Patient problems
- No Consequences Or Impact To Patient3
- No Code Available2
VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM models
140 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall2 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall2 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall1 report
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Screw, Fixation, Bone1 recall0 reports
Recent VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM adverse event reports
The 5 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 17, 2018Mechanical Problem; Mechanical Problem
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: FOOT; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT INFORMATION: METATARSAL FRACTURE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: PER REPRESENTATIVE. USING A 4 HOLE REDUCE PLATE TO FIX A 4TH METATARSAL FRACTURE, A 1.5 DRILL BIT WAS USED TO PREPARE ENTRY HOLE FOR THE RIVAL 2.0 SCREW. THE 2.0 SCREWS WERE DIFFICULT TO INSERT AND EVENTUALLY SNAPPED OFF AT THE HEAD. THE REMAINING SCREW WAS NOT REMOVED FROM THE PATIENT. IT WAS PLATED OVER USING A SYNTHES PLATE. A 4 HOLE PLATE WAS ALSO USED ON THE 5TH METATARSAL AND THREE OUT OF THE 4 SCREWS STRIPPED A THE DRIVER SCREW HEAD INTERFACE. THIS IMPLANT WAS EVENTUALLY SEATED AND IS IN PATIENT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ANY ADVERSE EFFECTS ON PATIENT; THE SURGERY WAS NOT COMPLETED WITH THE DEVICE; A REPLACEMENT DEVICE WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY (PLATED OVER USING A SYNTHES PLATE); THE EVENT LED TO A CLINICALLY REL
Patient problems: No Code Available
MAUDE report 7436043 ↗InjuryApr 17, 2018Mechanical Problem; Mechanical Problem
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6); - SURGEON NAME: (B)(6); - DATE OF SURGERY: (B)(6) 2018; - BODY PART TO WHICH DEVICE WAS APPLIED: FOOT; - SURGERY DESCRIPTION: FRACTURE TREATMENT; - PATIENT INFORMATION: METATARSAL FRACTURE; - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: PER REPRESENTATIVE. USING A 4 HOLE REDUCE PLATE TO FIX A 4TH METATARSAL FRACTURE, A 1.5 DRILL BIT WAS USED TO PREPARE ENTRY HOLE FOR THE RIVAL 2.0 SCREW. THE 2.0 SCREWS WERE DIFFICULT TO INSERT AND EVENTUALLY SNAPPED OFF AT THE HEAD. THE REMAINING SCREW WAS NOT REMOVED FROM THE PATIENT. IT WAS PLATED OVER USING A SYNTHES PLATE. A 4 HOLE PLATE WAS ALSO USED ON THE 5TH METATARSAL AND THREE OUT OF THE 4 SCREWS STRIPPED A THE DRIVER SCREW HEAD INTERFACE. THIS IMPLANT WAS EVENTUALLY SEATED AND IS IN PATIENT. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ANY ADVERSE EFFECTS ON PATIENT; - THE SURGERY WAS NOT COMPLETED WITH THE DEVICE; - A REPLACEMENT DEVICE WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY (PLATED OVER USING A SYNTHES PLATE); - THE EVE
Patient problems: No Code Available
MAUDE report 7436041 ↗InjuryJan 23, 2018Mechanical Problem; Mechanical Problem
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6); - SURGEON NAME: (B)(6); - DATE OF SURGERY: (B)(6) 2017; - BODY PART TO WHICH DEVICE WAS APPLIED: FOOT; - SURGERY DESCRIPTION: NO RESPONSE; - PATIENT INFORMATION: (B)(6), MALE; - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT; - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: SCREWS FAILED DURING SURGERY, (B)(4) THREADS STRIPPED DURING INSERTION BUT WAS ABLE TO REMOVE (PLEASE KINDLY REFER TO MFR REPORT 9680825-2018-0002). (B)(4), ONE THREADS STRIPPED DURING INSERTION AND THE OTHER HEAD BROKE OFF AT THE NECK DURING INSERTION (PLEASE KINDLY REFER TO MFR REPORTS 9680825-2018-00003 AND 9680825-2018-00004). THEY REMAIN IN PATIENT. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT; - THE SURGERY WAS NOT COMPLETED WITH THE DEVICE; - A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY; - THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE (10 MINUTES); - AN ADDITIONAL SURGERY WAS NOT REQUIRED; - COPIES OF THE OPERATIVE REPORT ARE AVAILABLE (NOT RECEIVED); - COPIES OF
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7211655 ↗InjuryJan 23, 2018Mechanical Problem; Mechanical Problem
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF SURGERY: (B)(6) 2017; BODY PART TO WHICH DEVICE WAS APPLIED: FOOT; SURGERY DESCRIPTION: NO RESPONSE; PATIENT INFORMATION: (B)(6) YEARS, MALE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: SCREWS FAILED DURING SURGERY, 002-E-27018 THREADS STRIPPED DURING INSERTION BUT WAS ABLE TO REMOVE (PLEASE KINDLY REFER TO MFR REPORT 9680825-2018-0002). THE 002-E-27014, ONE THREADS STRIPPED DURING INSERTION AND THE OTHER HEAD BROKE OFF AT THE NECK DURING INSERTION (PLEASE KINDLY REFER TO MFR REPORTS 9680825-2018-00003 AND 9680825-2018-00004). THEY REMAIN IN PATIENT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT; THE SURGERY WAS NOT COMPLETED WITH THE DEVICE; A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY; THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE (10 MINUTES); AN ADDITIONAL SURGERY WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORT ARE AVAILABLE (NOT RECEIVED); COPIES OF THE X-RAY I
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7211654 ↗InjuryJan 23, 2018Mechanical Problem; Mechanical Problem
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF SURGERY: (B)(6) 2017; BODY PART TO WHICH DEVICE WAS APPLIED: FOOT; SURGERY DESCRIPTION: NO RESPONSE; PATIENT INFORMATION: (B)(6), MALE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: SCREWS FAILED DURING SURGERY, (B)(4) THREADS STRIPPED DURING INSERTION BUT WAS ABLE TO REMOVE (PLEASE KINDLY REFER TO MFR REPORT 9680825-2018-0002). (B)(4), ONE THREADS STRIPPED DURING INSERTION AND THE OTHER HEAD BROKE OFF AT THE NECK DURING INSERTION (PLEASE KINDLY REFER TO MFR REPORTS 9680825-2018-00003 AND 9680825-2018-00004). THEY REMAIN IN PATIENT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT; THE SURGERY WAS NOT COMPLETED WITH THE DEVICE; A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY; THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE (10 MINUTES); AN ADDITIONAL SURGERY WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORT ARE AVAILABLE (NOT RECEIVED); COPIES OF THE X-RAY IMAGES ARE AVAILABLE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7211653 ↗
Other Orthofix Srl products
- ORTHOFIX MODULSYSTEM15 models · 13 reports · 4 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.
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