ORTHOFIX MODULSYSTEM 1 (REF M511)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18032568866544), received between Dec 10, 2018 and Dec 10, 2018 — classified as 1 injury.

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. 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.

• 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 ↗

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-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-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-0380-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603
• Z-0389-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
• 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
• 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-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-0382-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
• 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-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-0393-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
• Z-0387-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
• 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-0386-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648

…and 8 more.