VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1 (REF 002-D-20014)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18056099645645), received between Apr 17, 2018 and Apr 17, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

1 FDA recall record name this device's identifier.

14 other recalls cover devices cleared under the same FDA submission (K140876); 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.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140876. One submission often covers many models, so check the product and lot details in each record.

• Z-2121-2018 · Apr 6, 2018 · Terminated
  Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008); b) D 2.7MM X 10MM (002-D-27010); c) D 2.7
• Z-2124-2018 · Apr 6, 2018 · Terminated
  Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014)
• Z-2130-2018 · Apr 6, 2018 · Terminated
  L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
• Z-2122-2018 · Apr 6, 2018 · Terminated
  Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010); c) D 2.7MM X 12MM (002-E-27012
• Z-2126-2018 · Apr 6, 2018 · Terminated
  CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
• Z-2135-2018 · Apr 6, 2018 · Terminated
  Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
• Z-2132-2018 · Apr 6, 2018 · Terminated
  Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)
• Z-2127-2018 · Apr 6, 2018 · Terminated
  Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006); b) 8MM Spacer (022-H-00008); c) 10MM Spacer (002-H-00010); d) 12M
• Z-2129-2018 · Apr 6, 2018 · Terminated
  Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-0100
• Z-2133-2018 · Apr 6, 2018 · Terminated
  TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-01030)
• Z-2131-2018 · Apr 6, 2018 · Terminated
  MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)
• Z-2120-2018 · Apr 6, 2018 · Terminated
  Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010); c) D 2.0MM X 1
• Z-2134-2018 · Apr 6, 2018 · Terminated
  T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)
• Z-2123-2018 · Apr 6, 2018 · Terminated
  Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-320