ORTHOFIX MODULSYSTEM 1 (REF 99-91647UE)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18032937169719), received between Nov 27, 2024 and Nov 27, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• 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 ↗

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-0388-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
• 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-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-0383-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
• 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-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-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-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-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-0378-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966
• 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-0389-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
• Z-0391-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
• 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-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

…and 8 more.