ORTHOFIX MODULSYSTEM 1 (REF 99-91080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18032568863352), received between Jun 25, 2024 and Jun 25, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

23 other recalls cover devices cleared under the same FDA submission (K955848); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955848. One submission often covers many models, so check the product and lot details in each record.

• Z-0390-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
• Z-0389-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
• Z-0373-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
• Z-0393-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
• Z-0379-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137
• Z-0388-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
• Z-0386-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648
• Z-0377-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
• Z-0375-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
• Z-0381-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068
• Z-0385-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918
• Z-0374-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
• Z-0384-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901
• Z-0392-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
• Z-0376-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867

…and 8 more.